Senior Quality Assurance Engineer

Location: Marlborough, MA
Employment Type: Full-Time, On-Site
Salary Range: $93,039-$123,277/year

Position Summary

A growing medical device division within a global photonics organization is seeking a Senior Quality Assurance Engineer to support manufacturing quality, supplier management, process validation, and overall compliance with ISO 13485 and FDA QSR standards. This role partners closely with engineering, suppliers, and manufacturing teams to ensure high-quality products throughout the full product lifecycle.

Key Responsibilities

Supplier Quality & Nonconformance Management

• Support and manage supplier SCARs, NCMRs, and complaint-related corrective actions
• Evaluate rework, nonconformances, and investigate supplier-related issues
• Participate in supplier audits and support supplier approval processes

Manufacturing Support & Design Transfer

• Provide sustaining support for engineering changes and process improvements
• Assist in design transfer activities from R&D to manufacturing
• Maintain and update DHRs, BOMs, routers, and specifications

Material & Product Quality

• Investigate and disposition material nonconformances
• Participate in MRB meetings and follow up with suppliers
• Review incoming inspection results for components and subsystems

Validation & Risk Management

• Lead and support IQ/OQ/PQ process validations
• Conduct Test Method Validations and Gage R&R studies
• Maintain and create ISO 14971 risk files and hazard analyses

Quality Systems, Documentation & Compliance

• Ensure compliance with ISO 13485 and 21 CFR 820 regulations
• Lead investigations for quality issues, audit findings, and customer complaints
• Support CAPA development and drive continuous improvement
• Author and revise SOPs, work instructions, and test methods

Root Cause Analysis & Data-Driven Problem Solving

• Apply advanced RCA tools (DOE, ANOVA, capability studies, tolerance intervals)
• Use statistical software (Minitab preferred) to analyze quality trends
• Develop data-driven corrective and preventive actions

Qualifications

• Bachelor's degree in Engineering or a technical field
• 5-7 years of Quality Engineering experience in the medical device industry
• Hands-on experience with process validation (IQ/OQ/PQ)
• Experience with Test Method Validation and Gage R&R
• Strong understanding of ISO 13485, 21 CFR 820, and ISO 14971
• Experience with electro-mechanical assemblies, fiber optics, cleanroom processes, or ESD controls
• Strong technical writing, documentation, and investigation skills
• Proficiency with Microsoft Office; Minitab or statistical software preferred
• Supplier quality experience a plus
• Start-up or fast-paced environment experience preferred

Physical & Technical Requirements

• Ability to work on-site in a manufacturing and engineering environment
• Comfortable working around electro-mechanical assemblies and laser/optical systems
• Ability to read specifications, engineering drawings, and technical documents
• Ability to sit, stand, talk, hear, and adjust visual focus during inspections or validations
• Basic computer proficiency (Word, Excel, databases, QMS or PLM systems)