This role is a unique opportunity to support new product and technology launches at the frontier of molecular diagnostics and personalized medicine. This position’s main responsibility is to support the R&D group on new product development and transfers to manufacturing. Other responsiblities include ensuring that products are designed in accordance with the Quality System and optimizing use of the Design Control process to result in a streamlined, compliant, scaleable system. This includes compliance with Quality System Regulation (QSR), ISO, CMDR, IVDD Regulations. Supports and provides assessments of Quality Management Feedback Processes: Nonconformances/CAPA, Complaints, External and Internal Audits, Management Reviews, Design Control. This is an independent contributor role, who would normally receive no instructions on routine work, and general instructions on new assignments. This is an opportunity for a highly motivated quality engineer to work in a fast-paced environment and support molecular diagnostics at the cutting edge of technology and medicine
- Responsible for evaluating, developing and implementing Quality System Feedback Processes to achieve goals in accordance with established QSR, ISO, CMDR and IVDD Regulations.
- Provides support and guidance to R&D in creating Design History Files, including but not limited to review and approval of design control documents, process and test method validation protocols/reports, risk analyses, manufacturing and QC documentation.
- Coordinating the completion of batch record review for final review and QA release.
- In analyzing situations or data, exercises sound judgment within defined procedures and practices to determine appropriate action.
- Participate on Project Teams as a contributing member and assist with audits as required.
- Develops and implements Quality System procedures as directed.
- Provides guidance to the R&D Core Team, advice and guidance to process owners on defined Quality Systems procedures and policies.
- May also conduct training on Quality System Regulations, and other duties as directed.
- The Quality Systems (QS) Analyst ensures Good Manufacturing Practice (GMP) compliance for all products developed and transferred to manufacturing at the Thermo Fisher CDD Fremont facility.
- 5-7 years of experience within the medical device industry including NPD, internal/external auditing, project management experience.
- BS degree in technical field or equivalent experience.
- Must have particiated in launch of at least one 510k product.
- Strong knowledge of cGMP and Quality Systems required.
- Must have excellent written and oral communication skills, and a strong track record of working cross functionally.
- Must have demonstrated ability to think strategically.
- Demonstrated ability to manage multiple activities and tasks.