Sr Quality Assurance Engineer (Onsite - Acton,MA)

Insulet Corporation•Acton, MA

22h•$87,300 - $130,950•Onsite

About The Position

The Senior Quality Assurance Engineer provides quality engineering support for medical device manufacturing and helps ensure quality, safety, and regulatory compliance. The role serves as a key quality representative for production operations, partnering with manufacturing, engineering, operations, and quality teams to resolve day-to-day issues, investigate nonconformances, lead root cause analyses, manage CAPAs, support process validations, and drive continuous improvement. The position applies quality systems, risk management, statistical analysis, and regulatory standards including FDA regulations, ISO 13485, and ISO 14971. It also supports audits and inspections, reviews manufacturing documentation, contributes to product release activities, and mentors junior Quality Assurance engineers. The position requires significant quality engineering experience in the medical device industry, strong analytical and technical writing skills, and the ability to manage multiple priorities in a fast-paced manufacturing environment. This is an on-site role requiring work at an office, plant, or lab in Acton, Massachusetts. The annual base salary range is $87,300 to $130,950. The position may also be eligible for incentive compensation.

Requirements

Bachelor’s degree in engineering (Mechanical, Biomedical, Electrical, Manufacturing, Materials Science, or a related discipline), or an equivalent combination of education and experience.
At least 5 years of Quality Engineering experience.
At least 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.
Ability to prioritize multiple competing deliverables simultaneously.
Computer proficiency, particularly with Microsoft Excel.

Nice To Haves

ASQ Certified Quality Engineer (CQE) certification.
Working knowledge of FDA Quality System Regulation (21 CFR Part 820) and ISO 13485 quality system standards.
Auditor training certification to ISO 13485.
Strong working knowledge of ISO 14971 risk management.
Ability to analyze and interpret complex data sets and test results using Excel, Minitab, or other statistical software.
Experience supporting FDA inspections, MDSAP audits, and notified body audits.

Responsibilities

Provide daily quality engineering support to manufacturing operations and serve as the primary quality engineering representative for production-related issues.
Perform and complete root cause investigations for in-process and Lot Qualification nonconformances using structured problem-solving methodologies.
Review and assess manufacturing deviations, nonconformances, and quality events.
Develop or manage quality programs to resolve issues arising from manufacturing operations and post-manufacturing activities.
Participate in operations and engineering meetings and provide quality guidance on operational decisions.
Assist with or lead CAPAs and cross-functional projects, and drive implementation and verification of corrective and preventive actions.
Ensure manufacturing documentation accurately reflects approved processes and quality requirements.
Provide validation support using quality tools and methods including FMEA, dFMEA, pFMEA, IQ, OQ, PQ, control plans, process verification and validation plans, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC.
Write and review process and test method validation protocols and reports, including reports for gauge R&R analysis.
Assist in developing risk-based assessments to determine inspection requirements and acceptance criteria.
Participate in or lead Material Review Board activities, review metrics and nonconformance 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.
Perform other duties as required.