Principal Quality Engineer, Post-Market Surveillance

• Analyze statistical data and product specifications to determine standards and establish quality and reliability objectives of finished product
• Develop and execute a Post Market Surveillance Master Schedule and lead post market surveillance (PMS) activities according to EU MDR requirements including trend analyses, signal assessments and project investigations. to maintain business continuity and efficiency post EUMDR implementation of BVI
• Direct workers engaged in product measurement, inspection, and testing activities to ensure quality control and reliability.
• Responsible for leading, creating and maintaining post market surveillance documents including post market surveillance plans and reports (Post Market Surveillance Report / Periodic Safety Update Reports) according to relevant U.S. and International medical device quality regulatory requirements including European Union Medical Device Regulation (EU MDR), Medical Device Directive/Medical Device Regulation, EN ISO 13485, EN ISO 14971, IEC 62366, and 21 CFR 820, 822, 803
• Support implementation of BVI EU to maintain business continuity and efficiency post EUMDR
• Coordinate and implement quality control objectives, activities, or procedures to resolve production problems, maximize product reliability, or minimize costs.
• Develop and maintain Quarterly Work Plans and Development Plans for all associates consistent with Global policies
• Support the Final regulatory (EU / FDA) submission for Project, develop and conduct post market clinical follow-up (PMCF) plans and reports to gather data on clinical performance and safety
• Responsible for actively monitoring and trending product performance (collection, evaluation and analysis of internal and external data sources like complaint data, adverse events, CAPAs, recalls, comparator and market data, feedback, etc.)
• Creating and maintaining different dashboards/ data visualization applying statistical methods and mathematical calculations in Microsoft Office Suite, including analytical or business intelligence tools (Macros, Tables, Look-ups, etc.) and Minitab Statistical Analysis Software. to support different initiatives on the post market surveillance team
• Act as subject matter expert for Post Market Surveillance data analytics and processes by leading and developing PMS data requirements and processes and owning and implementing internal procedures to comply with global post market surveillance regulations.
• Work cross-functionally with various departments (medical affairs, research and development, risk management, quality, manufacturing, regulatory, marketing and clinical affairs) to ensure PMS processes are adequately implemented at a global level across several business units
• Regulate and alter workflow schedules according to established manufacturing sequences based on Post Market Surveillance data analytics
• Support Business Development opportunities as required; and act as subject matter expert in internal and external audits.

• Master’s degree in industrial engineering or a directly related field
• 2+ years of Quality Engineering experience in the medical device industry.
• Telecommuting acceptable.
• Knowledge of and experience with relevant U.S. and International medical device quality regulatory requirements including European Union Medical Device Regulation (EU MDR), Medical Device Directive/Medical Device Regulation, EN ISO 13485, EN ISO 14971, IEC 62366, and 21 CFR 820, 822, 803
• Experience developing and conducting post market clinical follow-up (PMCF) plans and reports to gather data on clinical performance and safety.
• Experience leading post market surveillance (PMS) activities according to EU MDR requirements including trend analyses, signal assessments and project investigations
• Knowledge of and experience with U.S. Food and Drug Administration (FDA), International Organization for Standardization (ISO) and Medical Device Coordination Group (MDCG) industry quality requirements associated with post market surveillance.
• Experience in use of Microsoft Office Suite, including analytical or business intelligence tools (Macros, Tables, Lookups, etc.) and Minitab Statistical Analysis Software; and Lean Six Sigma Certification.

BVI® is refocusing the future of vision.
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.
We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more at www.bvimedical.com