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- Responsible for supporting the development of new or improved In Vitro Diagnostics products and Laboratory Developed Tests as core team Design Quality Engineering lead; providing collaborative, delivery oriented technical guidance, and support.
- Responsible for ensuring all quality requirements are met for global launch of new products.
- Lead on-time completion of Design Control outputs. Assist in the determination of appropriate outputs and generating project timelines as well as sustainability & improvement of existing products.
- Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements.
- Ensure DHF content completion, integrity, and regulatory & standards compliance; communicating & resolving gaps.
- Ensure compliance with quality systems and regulatory requirements related to product, process, specification & process design.
- Provide Quality guidance to new product development teams in the areas of validation, design transfer, risk management and specification development.
- Participate in Design Verification, Validation, and Process Validation Planning, Protocol Review, Report Review.
- Performs design change control activities including impact assessments, reviews, and approvals.
- Takes lead role in CAPA, non-conformances, and planned deviations activities such as investigation, implementation, or verification of effectiveness as required.
- Supports risk management activities in relation to product development and post market surveillance requirements.
- Provide technical support during audits (internal and third-party)
- Prepare and develop documentation to support design history files and regulatory submissions, ensuring documents are complete and accurate.
- Propose, plan, and deliver improvement projects, as required for product sustainability using Continuous Improvement techniques.
- Participate in Material Review Board (MRB) and Change Review Board meetings as required.
- Able to challenge opinions based on specialist knowledge which will involve discussing complex and confidential information.
- To build and maintain up-to-date knowledge from private study and training, and to share that knowledge with colleagues.
- Lead quality actions as part of project teams
- Maintaining, and improving our Hardware and Software product lifecycle management process following IEC 62304
- Supporting software product management activities.
- degree in a relevant scientific or engineering background.
- Previous experience working in a regulated IVD medical device, biotech, or pharmaceutical industry.
- Knowledge of relevant regulations including: 21 CFR Part 820, ISO 13485, ISO 14971.
- Knowledge of software and hardware regulations related to IVD
- Experience with process validation, analytical method validation, and equipment qualifications
- Knowledge of medical device domestic and international standards.
- Awareness of continuous improvement techniques
Engineer III, QA - Birmingham, United Kingdom - Thermo Fisher Scientific
Description
Education And Experience:
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.