Senior Quality Assurance Engineer

We are seeking a Quality Assurance (QA) Engineer to join our team onsite in Marlborough, MA
. In this role, you will collaborate closely with suppliers, development teams, and manufacturing teams to ensure quality excellence throughout the product lifecycle. This includes supporting Design Transfer activities and maintaining compliance with medical device regulations.

• Support SCAR processes and manage supplier nonconformances and rework evaluations
• Handle supplier-related internal NCMRs, CAPAs, and corrective actions for complaints

• Provide sustaining support for process improvements and design changes entering manufacturing
• Assist with design transfer and maintain key manufacturing documentation (DHRs, routers, BOMs, specs)

• Investigate and disposition material nonconformances; participate in MRB meetings
• Perform incoming inspection reviews and disposition components/subsystems
• Assess proposed changes for validation impact (processes, equipment, materials)
• Maintain and create product-specific risk files per ISO 14971

• Support the calibration system
• Develop and update procedures, work instructions, and test methods

• Document all QA activities in compliance with medical device standards and regulations
• Lead investigations into quality issues, complaints, and audit findings
• Support CAPA processes and promote QMS improvements
• Support onboarding and management of approved suppliers
• Participate in internal and supplier audits

• Apply root cause analysis and structured problem-solving tools
• Make data‑driven decisions and propose risk‑based solutions

• Bachelor’s degree in engineering or related technical field
• 5–7 years of manufacturing quality experience within the medical device industry
• Hands‑on experience with process validation, test method validation, Gage R&R
• Experience with ISO 14971 risk management activities

• Strong knowledge of advanced statistical methods:
  Hypothesis testing, DOE, ANOVA, R&R, capability analysis, tolerance interval analysis, power & sample size
• Proficiency with statistical software (e.g.,
  Minitab
  ) preferred
• Extensive knowledge of 21 CFR Part 820 and ISO 13485
• Hands‑on experience with manufacturing processes (electro‑mechanical assembly, ESD controls, clean room ops, cabling, labeling, sterilization, fiber optics)
• Excellent documentation skills for protocols and reports
• Ability to analyze quality data and identify improvement opportunities