QA Engineer

In this fully onsite role, the QA Engineer supports product developments and provides quality oversight to the R&D activities while working within a multi-functional team environment for medical devices.The QA Engineer will play an active role to ensure the design and development process meets quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements as well as being involved in QA activities.

Essential Duties and ResponsibilitiesQA focal point for R&D projects in design and development processes.Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standardsResponsible for final approval of R&D and lab documentation- reviewing and approving technical and DHF documentation and lab work instructions/test method.Responsible for approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, protocols, reports, product design transfer)Responsible for approval of product design changes and process changes (ECO)Finding solutions for queries within responsibility limitsAssist and provide guidance on any out of specification result, deviation, or excursion that may occurQA representative in product development design reviewsWork cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projectsAttend program meetings as required as part of extended program teamsResponsible for approval of labellingRequirements: B.Sc. in Science or Engineering requiredWork ExperienceMinimum 2 years of experience in Medical Device / Pharma industry requiredExperience with Medical Device Design & Development, Verification Activities, Risk Management, Product Transfer, DHF Activities preferredStrong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971 preferredThis position is open to all candidates.