Sr Quality Assurance Engineer (Onsite - Acton,MA)

Position Overview 

The Senior Quality Assurance Engineer plays a key role in providing quality engineering support for medical device manufacturing while ensuring the highest standards of quality, safety, and regulatory compliance. This position offers the opportunity to work cross-functionally with operations, engineering, manufacturing, and quality teams driving the timely resolution of day-to-day manufacturing issues, nonconformances, and process improvements while ensuring compliance with FDA regulations, ISO 13485, ISO 14971, and internal quality system requirements.  

This Senior Quality Assurance Engineer takes a leadership role in problem-solving activities, risk assessments, investigation execution, and continuous improvement initiatives to ensure the consistent production of safe and effective medical devices. 

Responsibilities 

• Provide daily quality engineering support to manufacturing operations and serve as primary quality engineering representative for production-related issues. 

• Perform and complete root cause investigations for nonconformances in-process and Lot Qualification. Conduct root cause analysis using structured problem-solving methodologies. 

• Review and assess manufacturing deviations, nonconformances, and quality events. 

• Develop and/or manage quality programs related to resolution of issues arising from manufacturing operations as well as post manufacturing activities.  

• Participate in operations and engineering meetings and provide quality guidance on operational decisions. 

• Assist or leads CAPAs and other cross-functional projects. Drive implementation and verification of corrective and preventative actions cross-functionally. 

• Ensure manufacturing documentation accurately reflects approved processes and quality requirements. 

• Provide validation support by applying manufacturing quality tools including, but not limited to: FMEA, dFMEA, pFMEA, IQ, OQ, PQ, control plans, process verification/validation plans, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC. 

• Write and review protocols and reports of Process and Test Method Validations. Write complete protocols and write reports for gauge R&R analysis. 

• Assist in the development of risk-based assessments to determine inspection requirements and acceptance criteria. 

• Participate and/or lead Material Review Board to review metrics, non-conformance activities, and support disposition decisions. 

• Train and mentor junior Quality Assurance engineers. 

• Support internal audits, external audits, and regulatory inspections. 

• Support product release initiatives and tasks as needed. 

• Performs other duties as required. 

Minimum Requirements 

• Bachelor’s degree in engineering (Mechanical, Biomedical, Electrical, Manufacturing, Materials Science, or related discipline) or equivalent combination of education and experience. 

• Minimum of 5 years of experience of Quality Engineering 

• Minimum of 3 years of experience supporting medical device manufacturing 

• Experience leading nonconformance investigations, CAPAs, and root cause analyses. 

• Experience working directly with manufacturing teams in a production environment. 

• Strong analytical, troubleshooting, and decision-making skills. 

• Excellent technical writing and communication skills. 

Preferred Skills and Competencies 

• ASQ Certified Quality Engineer (CQE) certification. 

• Working knowledge of the Quality System Regulation (FDA 21CFR Part 820) and ISO 13485 quality system standards. 

• Auditor training certification to ISO 13485. 

• Strong working knowledge of ISO 14971 Risk Management. 

• Strong analytical skills and troubleshooting skills. Ability to analyze and interpret complex data sets and test results in Excel, Minitab, or another statistical software. 

• The ability to prioritize multiple competing deliverables simultaneously. 

• Computer proficiency in MS, specifically Excel. 

• Experience supporting FDA inspections, MDSAP audits, and notified body audits. 

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite