25 days old

Quality Engineer

Common Sensing
Cambridge, MA 02139
  • Job Code
    115507397

Responsibilities:

New Product Development (approximately 35% of the work):

  • Actively execute quality assurance in design development, including but not limited to:
  • Write, review and support the development of design and development plans for new products or design changes of existing products.
  • Write, review and support the development of risk management documentation, such as risk management plans, risk analysis, FMEA's, risk management report, etc.
  • Writing and approving test protocols and reports.
  • Executing validation and verification activities.
  • Contribute to the development and maintenance of Design History Files/ Design and Development Files, as well as Technical Files.

Quality Management System (approximately 35% of the work):

  • Ensure that quality system requirements are effectively maintained in compliance with FDA 21 CFR Part 820 and ISO 13485:2016.
  • Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
  • Contribute to the achievement of the quality objectives.
  • Participating in Common Sensing's QMS audits.
  • Execution and record generation of key QMS process, including but not limited to:
  • NCR's.
  • Complaints.
  • CAPA.
  • Contribute to creation of Management Review records.
  • Contribute to management of suppliers.

Production Quality (approximately 30 % of the work):

  • Actively execute quality assurance in production, including but not limited to:
  • Performing quality final lot release for finished product before being released for distribution, including review of of production data from contract manufacturer.
  • Support the investigation of technical problems and evaluate & implement solutions.
  • Perform other acceptance activities, as required, in accordance with Common Sensing SOP-9.

Expectations for team engagement:

  • Proactive leadership around developing a pro-quality culture at Common Sensing.
  • Actively engage with team to optimize quality related workflows.
  • Actively train team and proactively provide advice around QSR.
  • Report quality metrics to management on a regular basis.

Expectations for external engagement:

  • Interact with team members including quality and regulatory consultants.
  • Support communications with notified bodies and regulatory agencies.
  • Support communications with Common Sensing partners as it relates to Quality.

Authority

  • Represent Common Sensing Quality Department to internal customers and external customers.
  • Reporting on the performance and effectiveness of the quality system and any need for improvement to Quality Department management for review.

<p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Responsibilities:</p> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><strong style="background: 0px 0px; border: 0px; box-sizing: inherit; font-size: 16px; font-weight: 600; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">New Product Development</strong> (approximately 35% of the work):</p> <ul style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; list-style-type: disc; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Actively execute quality assurance in design development, including but not limited to:</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Write, review and support the development of design and development plans for new products or design changes of existing products.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Write, review and support the development of risk management documentation, such as risk management plans, risk analysis, FMEA's, risk management report, etc.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Writing and approving test protocols and reports.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Executing validation and verification activities.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Contribute to the development and maintenance of Design History Files/ Design and Development Files, as well as Technical Files.</li> </ul> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><strong style="background: 0px 0px; border: 0px; box-sizing: inherit; font-size: 16px; font-weight: 600; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Quality Management System</strong> (approximately 35% of the work):</p> <ul style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; list-style-type: disc; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Ensure that quality system requirements are effectively maintained in compliance with FDA 21 CFR Part 820 and ISO 13485:2016.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Contribute to the achievement of the quality objectives.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Participating in Common Sensing's QMS audits.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Execution and record generation of key QMS process, including but not limited to:</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">NCR's.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Complaints.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">CAPA.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Contribute to creation of Management Review records.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Contribute to management of suppliers.</li> </ul> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><strong style="background: 0px 0px; border: 0px; box-sizing: inherit; font-size: 16px; font-weight: 600; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Production Quality</strong> (approximately 30 % of the work):</p> <ul style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; list-style-type: disc; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Actively execute quality assurance in production, including but not limited to:</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Performing quality final lot release for finished product before being released for distribution, including review of of production data from contract manufacturer.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Support the investigation of technical problems and evaluate & implement solutions.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Perform other acceptance activities, as required, in accordance with Common Sensing SOP-9.</li> </ul> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Expectations for team engagement:</p> <ul style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; list-style-type: disc; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Proactive leadership around developing a pro-quality culture at Common Sensing.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Actively engage with team to optimize quality related workflows.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Actively train team and proactively provide advice around QSR.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Report quality metrics to management on a regular basis.</li> </ul> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Expectations for external engagement:</p> <ul style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; list-style-type: disc; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Interact with team members including quality and regulatory consultants.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Support communications with notified bodies and regulatory agencies.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Support communications with Common Sensing partners as it relates to Quality.</li> </ul> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><strong style="background: 0px 0px; border: 0px; box-sizing: inherit; font-size: 16px; font-weight: 600; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Authority</strong></p> <ul style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; list-style-type: disc; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Represent Common Sensing Quality Department to internal customers and external customers.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Reporting on the performance and effectiveness of the quality system and any need for improvement to Quality Department management for review.</li> </ul> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <img src="https://analytics.click2apply.net/v/b7Qzdet8bxg6hxEkIN4Jq"> <br/><br/><p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><strong style="background: 0px 0px; border: 0px; box-sizing: inherit; font-size: 16px; font-weight: 600; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Education, Experience and Background Requirements</strong></p> <ul style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; list-style-type: disc; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">2+ years of experience in a Quality role at a medical device company.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Background/education in engineering/science or related field.</li> </ul> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; font-weight: 400; color: rgba(0, 0, 0, 0.9); line-height: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><strong style="background: 0px 0px; border: 0px; box-sizing: inherit; font-size: 16px; font-weight: 600; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Training and Skills Requirements</strong></p> <ul style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px #ffffff; list-style-type: disc; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: pre-wrap; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Strong communication skills and experience working in small teams.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Relevant Quality related certifications (E.g. ASQ CQE) or equivalent experience.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Training in all Common Sensing's QMS processes.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">Ability to work with small teams and external suppliers & customers.</li> <li style="box-sizing: inherit; margin: 0px 0px 0px 16px; padding: 0px; border: 0px; font-size: 16px; vertical-align: baseline; background: 0px 0px;">This position is located in Cambridge, MA and will require approximately 20% domestic and international travel.</li> </ul><p>PI115507397</p>

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Posted: 2019-11-15 Expires: 2019-12-16

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Quality Engineer

Common Sensing
Cambridge, MA 02139

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