When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Under the direction of the Sr. Manager, Quality, the Senior Product Quality Engineer will be responsible for supporting New Product Development (NPD) design assurance by providing input to the development teams, authoring or approving Design Control deliverables such as Risk Management Files, Quality Plans, and Design Verification and Validation Plans. This position is also responsible for providing guidance and coaching for post market product sustaining activities, such as design changes and CAPA.
•Provides guidance on NPD projects for: User Need Specification, Design Specification, Design Verification, Design Validation, Test Method Validation, Risk Management File, Design Transfer and Design Reviews.
•Facilitates risk management activities for new products using Risk Assessment Documents and FMEAs, as applicable.
•Reviews and approves product specification documentation for new products
•Defines work breakdown structures and quality plans for NPD as required
•Ensures the DHF for new products is adequately maintained and complete prior to product launch
•Ensures design changes are captured and follow the design change control process
•Identifies the opportunities for continuous improvement of the Quality Systems, including the design control, risk management, document generation, and design testing processes
•Participates on team projects and assignments, facilitating or leading teams as necessary.
•Provides guidance to test method development/validation, sample plan definition, and design validation development.
•Provides guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.
•Provides coaching to teams on post market product design change projects and CAPA linked in the following areas:
•Use of risk management tools to evaluate impact of change
•Ensure product verification and validation requirements are reviewed and defined appropriately
•Represents Quality on Business Teams
•Customer Advocate - provide a direct link between customer and process quality, manufacturing, and engineering in Rochester
•Other duties as assigned
•Position requires a Bachelor’s of Science Degree in Engineering or equivalent experience, and 7 to 10 years direct Quality Engineering experience with expertise in Design Control for medical device industries
•Experience in regulated medical device manufacture with compliance to FDA Quality System Regulation, EU Medical Device Directive and ISO 13485 is required
•Working knowledge of EN ISO 14971:2012 and experience in utilization of Risk Management techniques (health hazard evaluation, fault tree analysis, dFMEA, pFMEA, etc) for medical devices is required
•Experience in Change Management is required
•Working knowledge of Excel, Word, Access, quality software, and statistical methods (SPC, DOE, Gauge R&R, etc.)
•Familiarity with test methods, sampling plans and standards for the design, verification, and validation of medical device products, including sterilization, biocompatibility, packaging validation is a plus.
•Project planning and advanced computer skills a plus.
•Plastic product manufacturing experience is a plus
•Experience in New Product Development from product realization to product launch as a technical function is a plus
•Experience in Process Validation (IQ/OQ/PQ) is a plus
•Demonstrated change agent for Quality Systems - that includes ability to challenge the status quo & effecting change to achieve business results.
•ASQ certification or Lean Six Sigma certification is a plus
•Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making and ambition.
•Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
•Leadership Skills: Proven ability to influence others and lead significant change.
•Strong communication skills both written and verbal
At Thermo Fisher Scientific, each one of our 50,000 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.