Senior Quality Assurance Engineer for Medical Devices

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life. Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society. Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits. Job Summary The Senior Quality Engineer is responsible for collaborating with suppliers, development teams, and manufacturing teams to perform QA activities. This includes, but is not limited to, supporting Design Transfer processes and ensuring quality standards are met throughout the product lifecycle. Key Responsibilities: Customer Management Quality point of contact for customers Support customer SCAR processes Handle internal NCMRs, CAPAs, and complaint corrective actions. Manufacturing & Process Support Provide sustaining support for process improvements and design changes transitioning into manufacturing. Assist in design transfer activities and maintain manufacturing documentation (MVP, MVR, DHRs, routers, BOMs, specifications). Material & Product Quality Investigate and disposition material nonconformances; participate in MRB meetings and follow up on supplier issues. Evaluate proposed changes to processes, equipment, or materials for validation impact. Generate and review process validation protocol and report documentation (TMV, IQ, OQ, PQ, MVP, MVR, Control Plans, Process Flow Diagrams) Maintain and create product-specific risk files in accordance with ISO 14971. Calibration & Documentation Assist with risk impact assessments for out of tolerance events. Develop and revise procedures, work instructions, and test methods. Quality Systems & Compliance Document activities in compliance with medical standards and regulations. Lead investigations into quality issues, complaints, and audit findings. Support CAPA processes and promote QMS awareness and improvement initiatives. Problem Solving & Decision Making Use root cause analysis and problem-solving tools to implement corrective actions. Make data-driven decisions and propose solutions based on calculated risks. Education and Experience Bachelor’s degree in engineering or a related technical field 5–7 years of manufacturing quality experience within the medical device industry Experience executing process validation and test method validation / Gage R&R activities Experience with risk management activities per ISO 14971 Required Skills and Abilities Working knowledge of advanced statistical methods, including Hypothesis testing, Design of Experiments (DOE), ANOVA, R&R studies, Capability analysis, Tolerance interval analysis, Power and sample size determinations Working knowledge of statistical software tools (e.g., Minitab) is preferred Extensive working knowledge of 21 CFR Part 820, ISO 13485 Strong proficiency in Microsoft Word and Excel Hands-on experience with manufacturing processes such as Electro-mechanical assembly, ESD controls, Clean room operations, Labeling, Sterilization, Fiber optics Strong documentation skills for protocol and report generation and review Ability to analyze quality data and trends to identify improvement opportunities #J-18808-Ljbffr IPG Medical Corporation