Thermo Fisher Scientific Quality Engineer II, Complaint Handling in Frederick, Maryland

Job Description

Job Title : Quality Engineer II, Complaint Handling

Requisition ID: 72882BR

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Responsibilities:

  • Leads the site complaint handling program for Class I, II & III IVD products including but not limited to evaluating, monitoring and investigating of customer complaints

  • Supports other site Quality Systems activities including but not limited to change control, training and internal audits

  • Ensures the quality system activities are in compliance with all applicable FDA quality system regulations as well as ISO 13485 and ISO 9001 in support of ASR, GPR, and IVD Class I, II and III products

  • Provides support for customer and Regulatory audits and inspections

  • Performs internal and external audits and supplier surveillance

  • Supports day-to-day site-specific quality needs for various, moderately complex products or product families. Examples include responding to non-routine quality complaints (e.g. performance related failures)

  • Identifies and implements improvements to processes, products, systems, and customer related quality issues.

  • Collaborates across function, leveraging others’ quality and manufacturing expertise to troubleshoot problems, interpret data, find root cause, determine next steps, and create technical reports

  • May provide guidance or direction to other lower-level personnel such as assistance with prioritization and investigations

  • Responsible for collecting data, performing moderately complex statistical analyses to investigate trends, provide interpretations, and draw conclusions at the site level

Minimum Qualifications :

  • Knowledge of International Standards ISO-9001, ISO-13485 and/or 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR)

  • Site specific software programs (change control notification program, CAPA, etc.).

  • Bachelor’s degree in biotech, science or engineering from accredited college/university or AA plus equivalent experience

  • Minimum of 3+ years related experience in Medical Device or Pharmaceutical Industry

  • Class II/III IVD complaint handling experience

Preferred Qualifications:

  • Masters of Science in molecular biology, chemistry, biochemistry, microbiology, engineering or related discipline preferred and/or MBA is highly desirable

  • Certification by the American Society for Quality (ASQ) as a Certified Quality Engineer (CQE) or Certified Quality Manager (CQMgr)

  • Experience with TrackWise, Agile, E1/SAP is a plus

This position is not approved for relocation assistance

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.