28 days old

Sr Quality Engineer - Early Development Quality

Amgen
Cambridge, MA 02138
  • Job Code
    118663662
Amgen

Job ID: R-95257
Location: Cambridge, MA, US 02139

Amgen is seeking a Senior Quality Engineer for the Final Product Technologies Early Development Quality team. We are seeking a highly motivated engineer, skilled in quality engineering and development of medical devices/combination products.

As a member of the Early Development team, you will be working closely with the engineers designing and testing the product, both within Amgen and with vendors. Your job will be focused on giving advice and quality oversight to projects developing technologies for medical devices and combination products in early development phases (concept/feasibility), i.e. before Design Controls entry.

You will have the opportunity to work on projects within primary container systems, drug delivery technologies such as auto injectors, electro-mechanical pumps, and pre-filled syringes. The role works closely with human factors engineering and you will be encouraged to collaborate with the project engineers to develop solutions that benefit patients and the business. Your will give advice on risk identification, mitigation development, requirements structuring and problem solving in the technology feasibility process. You will also support Human Factors activities, including Use Related Risk Assessments and task analysis creation.

As an early development quality engineer, you will support development partner and vendor onboarding and due diligence activities in the feasibility stages.

You will be part of the FPT Quality - Early Development Team, which is a small, recently established team of highly skilled and very supportive colleagues. This position is located in Cambridge, MA.

Key responsibilities:

  • Supports low to moderate complexity development programs.
  • Provides quality oversight of deliverables intended for further development and inclusion in Design History File.
  • Provides guidance on structure and systems (e.g. documentation management and requirements development) within good engineering practices to inform Quality by Design thinking.
  • Collaborate with process owners to integrate new requirements into the QMS due to novel technologies.
  • Collaborate with Product Complaints team to capture information on complaints to provide quality technical expertise on early development projects
  • Work with Product Quality Leads during drug delivery device feasibility
  • Collaborate with project teams on implementation plans in alignment with applicable guidance, regulations, and standards to enable future compliance
  • Provides support for Human Factors activities


Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Manufacturing, Quality or Engineering experience

OR

Bachelor's degree and 5 years of Manufacturing, Quality or Engineering experience

OR

Associate's degree and 10 years of Manufacturing, Quality or Engineering experience

OR

High school diploma / GED and 12 years of Manufacturing, Quality or Engineering experience

Preferred Qualifications

  • 5+ years of experience in development, quality, or manufacturing in medical device or combination product industry
  • Familiar with applicable regulations and guidance (e.g. MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211)
  • Working knowledge of technical standards (e.g., ISO 11608, ISO 10993 ISO 23908, IEC 60601)
  • Experience with assessment of potential vendors, partners, and suppliers
  • Experience with ideation and concept development, good engineering practices for testing and documentation, technology evaluation
  • Experience with device or combination product manufacturing equipment and processes.
  • Able to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Understanding of industry requirements/expectations of a process based QMS
  • Understanding of the applicable manufacturing/testing processes (i.e. Drug Product, Packaging, Device manufacturing processes)
  • Ability to travel +/- 20% of time to domestic and international locations


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI118663662

<b>Amgen</b><br/><br/><b>Job ID: </b>R-95257<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>Amgen is seeking a Senior Quality Engineer for the Final Product Technologies Early Development Quality team. We are seeking a highly motivated engineer, skilled in quality engineering and development of medical devices/combination products.<br><br>As a member of the Early Development team, you will be working closely with the engineers designing and testing the product, both within Amgen and with vendors. Your job will be focused on giving advice and quality oversight to projects developing technologies for medical devices and combination products in early development phases (concept/feasibility), i.e. before Design Controls entry.<br><br>You will have the opportunity to work on projects within primary container systems, drug delivery technologies such as auto injectors, electro-mechanical pumps, and pre-filled syringes. The role works closely with human factors engineering and you will be encouraged to collaborate with the project engineers to develop solutions that benefit patients and the business. Your will give advice on risk identification, mitigation development, requirements structuring and problem solving in the technology feasibility process. You will also support Human Factors activities, including Use Related Risk Assessments and task analysis creation.<br><br>As an early development quality engineer, you will support development partner and vendor onboarding and due diligence activities in the feasibility stages.<br><br>You will be part of the FPT Quality - Early Development Team, which is a small, recently established team of highly skilled and very supportive colleagues. This position is located in Cambridge, MA.<br><br><b><b>Key responsibilities:</b></b><br><br><ul><li>Supports low to moderate complexity development programs.</li><li>Provides quality oversight of deliverables intended for further development and inclusion in Design History File.</li><li>Provides guidance on structure and systems (e.g. documentation management and requirements development) within good engineering practices to inform Quality by Design thinking.</li><li>Collaborate with process owners to integrate new requirements into the QMS due to novel technologies.</li><li>Collaborate with Product Complaints team to capture information on complaints to provide quality technical expertise on early development projects</li><li>Work with Product Quality Leads during drug delivery device feasibility</li><li>Collaborate with project teams on implementation plans in alignment with applicable guidance, regulations, and standards to enable future compliance</li><li>Provides support for Human Factors activities</li></ul><br><br><b><b>Basic Qualifications</b></b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 3 years of Manufacturing, Quality or Engineering experience<br><br>OR<br><br>Bachelor's degree and 5 years of Manufacturing, Quality or Engineering experience<br><br>OR<br><br>Associate's degree and 10 years of Manufacturing, Quality or Engineering experience<br><br>OR<br><br>High school diploma / GED and 12 years of Manufacturing, Quality or Engineering experience<br><br><b><b>Preferred Qualifications </b></b><br><br><ul><li>5+ years of experience in development, quality, or manufacturing in medical device or combination product industry</li><li>Familiar with applicable regulations and guidance (e.g. MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211)</li><li>Working knowledge of technical standards (e.g., ISO 11608, ISO 10993 ISO 23908, IEC 60601)</li><li>Experience with assessment of potential vendors, partners, and suppliers</li><li>Experience with ideation and concept development, good engineering practices for testing and documentation, technology evaluation</li><li>Experience with device or combination product manufacturing equipment and processes.</li><li>Able to successfully manage workload to timelines</li><li>Familiarity with basic project management tools</li><li>Understanding of industry requirements/expectations of a process based QMS</li><li>Understanding of the applicable manufacturing/testing processes (i.e. Drug Product, Packaging, Device manufacturing processes)</li><li>Ability to travel +/- 20% of time to domestic and international locations</li></ul><br><br>Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.<br><br>Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.<br><br><b> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. </b><br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/KMdyKgiLJa2jipG7iXwaN"> <p>PI118663662</p>

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Posted: 2020-03-03 Expires: 2020-04-03

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Sr Quality Engineer - Early Development Quality

Amgen
Cambridge, MA 02138

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