Job
Description
Role & responsibilities: • Be a part of core project team and support the quality engineering across the entire development cycle Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects. Lead the development and implementation of design verification and validation plans with project design lead. Lead the development of Critical to Quality (CTQs), design input and output documents. Lead the fixture qualification and test method validation. Participate and implement tools like Design of Experiments (DOEs), FMEA sessions, Risk Management and ensure compliance to CTQs and safety requirements. Manage electronic document control and version control on all project related documents. Ensure adherence to the quality systems and design assurance SOPs and Boston Scientifics PLCP. Lead usability, reliability, testing, verification and validation testing internal and local vendors. Provide statistical testing and reliability plans. 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 applicable). 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 quality. Skill Sets: Must have - 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 with statistical analytical techniques and s/w tools like Keywords & Tools: Quality Management Systems 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. development of Critical to Quality (CTQs) Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). Well versed MATLAB, MINITAB. GD&T CQE certification, CAPA
