15 days old

Quality Assurance Complaints Analyst

Aesculap Inc.
Center Valley, PA 18034
  • Job Code
    117070829
Aesculap Inc.


Quality Assurance Complaints Analyst

US-PA-Center Valley

Job ID: 2019-15593
Type: Regular Full-Time
# of Openings: 3
Category: Quality
Aesculap Inc.

Overview

Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives.



Responsibilities

Position Summary:

The Quality Assurance Complaints Analyst on the Post Market team will participate in complaint and MDR handling activities for the purpose of ensuring compliance with US and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience.

Responsibilities: Essential Duties

  • Receive and process complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by Aesculap in a manner consistent with all laws and regulations for medical devices.
  • Maintains the Medical Device Reporting system using FDA eMDR (WebTrader) gateway.
  • Responds to FDA’s Request For Information (RFI) on any required MDRs
  • Generate and analyze customer feedback data to improve product reliability and performance for our customers.
  • Conduct follow up investigation on potential medical events including contacting hospital personnel
  • Assess complaint information for determination of adverse event reporting and/or vigilance reporting.
  • Monitors, evaluates and reports on complaint Product and triggers internal investigations (ATS).
  • Possess understanding of risk management concepts and is capable of assessing product risks.
  • Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action.
  • Oversight of critical Post Market projects and routinely share project goals, status, requirements, and deliverables to management.
  • Build key relationships with Product Managers to keep abreast of new technologies and product changes.
  • Communicate, work cross-functionally and consult frequently with Manufacturing, Operations, Service, Sales, Research and Development, Regulatory and Marketing.
  • Ensure completion of key deliverables.
  • Must embody the Company’s Vision, Mission and Values
  • Other duties may be assigned

Expertise: Knowledge & Skills

Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Ability to speak German and/or Spanish preferred.

Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.



Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

  • High School Diploma or equivalent in combination with 2+ years of Complaint Handling and/or MDR/Vigilance experience is required.
  • Bachelor’s degree in Life Science or Engineering discipline preferred.
  • BSN/RN with Licensure preferred (Prior Complaint Handling/MDR not required with this skillset).
  • Background in surgical Instruments, sterilization and Implants highly desirable.
  • Knowledge and application of complaint handling regulations, medical device reporting and other quality standards.
  • Knowledge of 21 CFR Part 820, Quality Systems Regulations.
  • Knowledge of 21 CFR Part 803, Medical Device Reporting.
  • Ability to drive results, foster teamwork, handle pressure, and provide feedback
  • Able to make judgment calls using combination of knowledge of regulations, knowledge of device technology, clinical experience, and critical thinking.
  • Ability to perform detail-oriented work with a high degree of accuracy.
  • Proven ability to work cross-functionally in a team based environment.
  • Proficient in MS Office Suite of products.
  • Willingness to be flexible and adaptable to changing priorities.
  • Excellent oral and written technical communication skills.
  • Effective analytical and problem solving skills.

Desired:

  • Background in surgical Instruments, sterilization and Implants highly desirable.
  • Knowledge of SAP preferred.
  • Knowledge of BDocs Preferred.
  • Full understanding of Good Manufacturing Practice (GMP) preferred.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.



All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

PI117070829

<b>Aesculap Inc.</b><br/><br/><br/><b>Quality Assurance Complaints Analyst</b><br/><br/>US-PA-Center Valley<br/><br/><b>Job ID:</b> 2019-15593<br/><b>Type:</b> Regular Full-Time<br/><b># of Openings:</b> 3<br/><b>Category:</b> Quality<br/>Aesculap Inc.<br/><br/><b>Overview</b><br/><br/><p style="margin-bottom: .0001pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif; color: black;">Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients lives.</span></p><br/><br/><b>Responsibilities</b><br/><br/><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif; color: black;">Position Summary:</span></strong></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">The Quality Assurance Complaints Analyst on the Post Market team will participate in complaint and MDR handling activities for the purpose of ensuring compliance with US and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience.</span></p><p style="margin: 0px;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif; color: black;"> </span></p><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif; color: black;">Responsibilities: Essential Duties</span></strong></p><ul><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Receive and process complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by Aesculap in a manner consistent with all laws and regulations for medical devices.</span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Maintains the Medical Device Reporting system using FDA eMDR (WebTrader) gateway. </span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Responds to FDAs Request For Information (RFI) on any required MDRs </span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Generate and analyze customer feedback data to improve product reliability and performance for our customers.</span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Conduct follow up investigation on potential medical events including contacting hospital personnel</span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Assess complaint information for determination of adverse event reporting and/or vigilance reporting.</span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Monitors, evaluates and reports on complaint Product and triggers internal investigations (ATS). </span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Possess understanding of risk management concepts and is capable of assessing product risks.</span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action.</span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Oversight of critical Post Market projects and routinely share project goals, status, requirements, and deliverables to management.</span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Build key relationships with Product Managers to keep abreast of new technologies and product changes. </span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Communicate, work cross-functionally and consult frequently with Manufacturing, Operations, Service, Sales, Research and Development, Regulatory and Marketing. </span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Ensure completion of key deliverables.</span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Must embody the Companys Vision, Mission and Values</span></li><li style="margin-left: 14.2pt;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Other duties may be assigned</span></li></ul><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif; color: black;">Expertise: Knowledge & Skills</span></strong></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><u><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Language Skills: </span></u><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Ability to read and interpret documents such as safety rules, operating </span><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">and maintenance instructions, and procedure manuals. Ability to write routine reports </span><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">and correspondence. Ability to speak effectively before groups of customers or </span><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">employees of organization. Ability to speak German and/or Spanish preferred. </span></p><p style="margin: 0in -1.1pt .0001pt 3.75in;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;"> </span></p><p style="margin-right: -1.1pt;"><u><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Mathematical Skills: </span></u><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. </span></p><p style="margin-right: -1.1pt;"> </p><p style="margin-right: -1.1pt;"><u><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Reasoning Ability:</span></u><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;"> Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. </span></p><br/><br/><b>Qualifications</b><br/><br/><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif; color: black;">Expertise: Qualifications - Experience/Training/Education/Etc</span></strong></p><p style="margin: 0px;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif; color: black;"> </span></p><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif; color: black;">Required:</span></strong></p><ul><li>High School Diploma or equivalent in combination with 2+ years of Complaint Handling and/or MDR/Vigilance experience is required.</li><li>Bachelors degree in Life Science or Engineering discipline preferred.</li><li>BSN/RN with Licensure preferred (Prior Complaint Handling/MDR not required with this skillset).</li><li>Background in surgical Instruments, sterilization and Implants highly desirable.</li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Knowledge and application of complaint handling regulations, medical device reporting and other quality standards.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Knowledge of 21 CFR Part 820, Quality Systems Regulations.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Knowledge of 21 CFR Part 803, Medical Device Reporting.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Ability to drive results, foster teamwork, handle pressure, and provide feedback</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Able to make judgment calls using combination of knowledge of regulations, knowledge of device technology, clinical experience, and critical thinking.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Ability to perform detail-oriented work with a high degree of accuracy.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Proven ability to work cross-functionally in a team based environment.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Proficient in MS Office Suite of products.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Willingness to be flexible and adaptable to changing priorities.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Excellent oral and written technical communication skills.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Effective analytical and problem solving skills.</span></li></ul><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif; color: black;">Desired:</span></strong></p><ul><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Background in surgical Instruments, sterilization and Implants highly desirable.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Knowledge of SAP preferred.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Knowledge of BDocs Preferred.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Full understanding of Good Manufacturing Practice (GMP) preferred.</span></li></ul><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif; color: black;">While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.</span></p><p style="margin: 0px;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif; color: black;"> </span></p><p style="margin: 0px;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif; color: black;"> </span></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif; color: black;">B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com </span></p><p style="margin: 0px;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif; color: black;"> </span></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif; color: black;">Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.</span></p><br/><br/>All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. <img src="https://analytics.click2apply.net/v/xW4Axocm6pjwso6NuGRrJ"> <p>PI117070829</p>

Categories

Posted: 2020-01-13 Expires: 2020-02-13

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Quality Assurance Complaints Analyst

Aesculap Inc.
Center Valley, PA 18034

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast