Quality Systems Engineer - Medical Devices - Tewksbury, MA

• Support and maintain compliance with the Quality Management System (QMS), including CAPA, NCMRs, Supplier Controls, Management and Risk Reviews.
• Coordinate and manage the CAPA program: administration, record keeping, quality input for investigations, reporting, and trend analysis.
• Assist CAPA owners with problem-solving techniques such as Root Cause Analysis, DOE, and FMEA.
• Manage the Internal Audit program: schedule audits, track findings, ensure timely corrective actions, and analyze audit metrics.
• Provide subject matter expertise and support during external audits and inspections.
• Develop, collect, and analyze quality metrics for monthly reviews and management meetings.
• Lead or participate in Risk Management and FMEA activities.
• Identify and implement Quality System improvements, including creating or revising documentation to close gaps.
• Escalate quality issues to leadership with clear data presentation to facilitate decision-making.
• Deliver training and support to employees on quality processes and procedures.
• Provide cross-functional quality assurance support across the organization.
• Support development and execution of quality plans, processes, and special projects as needed
• Onsite at our Tewksbury, MA location

• Bachelor's degree in Engineering, Biomedical Science, or a related technical field preferred.
• 5-7 years of relevant medical device industry experience with responsibility for Product Quality and/or Quality Systems.
• Working knowledge of Quality System regulations and standards, including 21 CFR Part 820, ISO 13485, and EU MDR.
• Experience in developing, documenting, and implementing quality procedures and processes.
• Proven ability to manage multiple projects and adapt to changing priorities effectively.
• Results-driven mindset with a strong sense of urgency and accountability.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Access.
• Experience in internal and external audits, preferably as a qualified internal auditor.
• Strong written and verbal communication skills for clear and effective information exchange.
• Independent judgment and decision-making capability in applying quality methods and evaluation.
• Solid problem-solving skills with the ability to identify and resolve issues proactively.
• Excellent interpersonal skills, able to collaborate across diverse cross-functional teams.
• Local to Tewksbury, MA

• Competitive base salary with comprehensive benefits package
• Access to a world-class laboratory and modern production facilities
• Onsite perks including free parking, fitness center, cafeteria, and coffee shop
• Robust health, dental, vision, and life insurance coverage
• Short- and long-term disability insurance
• 401(k) retirement savings plan with employee contribution options
• Flexible spending accounts for healthcare and dependent care needs
• Generous paid time off, including vacation and holidays
• Employee Stock Purchase Plan (ESPP)
• Fast-paced, mission-driven environment working on life-saving medical technology
• Opportunity to collaborate with highly skilled, innovative colleagues in a growing company

Michael Page