Sr. Quality Assurance Engineer

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 Quality Assurance (QA) 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:

• Supplier Management & SCAR Support
• Support SCAR processes and manage nonconformances and rework evaluations for assigned suppliers.
• Handle supplier-related 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 (DHRs, routers, BOMs, specifications).
• Material & Product Quality
• Investigate and disposition material nonconformances; participate in MRB meetings and follow up on supplier issues.
• Perform incoming inspection reviews and disposition of components and subsystems.
• Validation & Risk Management
• Evaluate proposed changes to processes, equipment, or materials for validation impact.
• Maintain and create product-specific risk files in accordance with ISO 14971.
• Calibration & Documentation
• Assist with calibration system maintenance.
• 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.
• Supplier Audits & Approvals
• Support management of new and approved suppliers.
• Participate in internal and supplier audits.
• 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
• Supplier management experience is preferred
• Proficiency with 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, Cabling, 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
• Prior start-up experience is a plus

MA: $93,039 - $123,277