Engineer III, DQA

Develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Be a part of core project team and lead the quality engineering across the entire development cycle. Support the development of CTQ's, design input and output documents. Support the fixture qualification and test method validation. Support the development and implementation of design verification and validation plans with project design lead. Support product risk management, usability, reliability and design validation efforts for new product development and design change projects. Participate and implement tools like Design of Experiments (DOE's), FMEA sessions, Risk Management and ensure compliance to CTQ's and safety requirements. Responsible for co-leading stage gate reviews and signatory on all PDP document approvals Manage electronic document control and version control on all project related documents. Support usability, reliability, testing, verification and validation testing - internal and local vendors. Provide statistical testing and reliability plans. Work closely with regulatory team to drive alignment of project documentation and regulatory requirements. Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution. Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applic Co-Lead CAPA efforts, 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). 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. Participate in ISO13485 site certification for the R&D center. Bachelors (or higher) degree in engineering with preference mechanical engineering. 5-7+ years of experience in medical device R&D quality engineering, systems and / or quality engineering supporting R&D projects, design assurance and documentation. Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation. Sound understanding of medical device regulatory requirements for Class II and III medical devices. Project planning - resourcing, timelines, quality and budgets. Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). Preference for candidates with CQE certification or similar training and experience Proficient in project management tools like MS project. Experience in GD&T Well versed with statistical analytical techniques and s/w tools like MATLAB, MINITAB.