Senior or Principal Quality Engineer
Looking for a technically-solid, hands-on Quality Engineer. Need someone who can hit the ground running and accelerate new projects. Need someone who is confident in their ability, and have a broad skill set for both R&D and MFG support, however this position will primarily focus on R&D projects: DFMEA’s, PFMEA’s, Statistical Analysis, and DV Protocols.
The Role: A New Product Development Quality Engineer is responsible for assuring all requirements are met for the Product Development Process (PDP), Risk Management, Design Controls and Usability Testing within technical development concepts and new product development. Works in fast paced Cross-Functional Teams to develop and support New Product Development, helping to ensure development of safe and effective new products. Supports Corporate Quality initiatives utilizing their PDP, Risk Management, and Design Controls expertise.
Execute Quality Deliverables: Lead the execution of Quality Deliverables such as Project Design & Development Plan, Design Verification and Validation Plans, Master Validation Plan. Lead the execution of the Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Lead product usability and design validation efforts for new product development and design change projects.
Design Controls: Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Design & Development Plan, Product Specification, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling) whether internal, co-developed or externally manufactured. Provide quality and regulatory guidance to assure country specific compliance to the laws and regulations of the targeted market for distribution. Champions 100% compliance to Company Policy and SOP’s. Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.
Transfer to Manufacturing: Partner with Manufacturing & Operations to define, develop, establish and implement quality requirements across the manufacturing process, including equipment and process validation, test method validation, incoming, in-process and final product inspection and process monitoring requirements.
Suppliers: Provide product specific supplier and co-development quality assurance expertise to Supplier Quality Engineering; conduct supplier audits when needed.
Audit Support: Support internal and external regulatory audits.
Product Support: Provide quality and compliance input and coaching for product development and/or post market product sustaining activities, such as design changes. Lead CAPA efforts, when assigned, and apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies). Will also lead studies for Biocompatibility & Sterilization Validations.
- BS in Engineering
- Minimum of 5-7+ years of Medical device engineering experience, directly supporting new product development for Class II or Class III products from initiation to
- In depth familiarity with the FDA, ISO, MDD, MDR and the medical device industry quality requirements associated with product development, design controls, and
product risk management.
- Detailed understanding and working knowledge of US and International regulations including 21 CFR 820, ISO 13485, ISO 14971, IEC 62366, Medical Device Directive, Medical Device Regulation.
- Strong communication and presentation skills.
- Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).