Quality Assurance Engineer (Onsite - Acton, MA)

Insulet Corporation•Acton, MA

22h•$70,400 - $105,650•Onsite

About The Position

The Quality Assurance Engineer provides quality engineering support for medical device manufacturing, ensuring that products and processes meet quality, safety, and regulatory requirements. The role works cross-functionally with manufacturing, engineering, operations, and quality teams to resolve day-to-day production issues, investigate nonconformances, conduct root cause analyses, support CAPAs, assist with process validations, and drive continuous improvement. The engineer applies quality engineering tools and risk management principles to resolve routine to moderately complex manufacturing issues and support production of safe and effective medical devices. The role also helps maintain compliance with FDA regulations, ISO 13485, ISO 14971, and internal quality system requirements; supports audits and inspections; and provides guidance on manufacturing documentation, process controls, and product release activities. The position requires onsite work at the office, plant, or lab in Acton, Massachusetts.

Requirements

Bachelor’s degree in engineering (Mechanical, Biomedical, Electrical, Manufacturing, Materials Science, or a related discipline), or an equivalent combination of education and experience.
3–5 years of Quality Engineering experience.
At least 2 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.

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 in Excel, Minitab, or other statistical software.
Ability to prioritize multiple competing deliverables simultaneously.
Computer proficiency in Microsoft applications, specifically Excel.
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, working cross-functionally and using structured problem-solving methodologies.
Review and assess manufacturing deviations, nonconformances, and quality events.
Participate in the Material Review Board to review metrics and nonconformance activities and support disposition decisions.
Develop and/or manage quality programs addressing 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 other 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 engineering 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 protocols and reports for process and test method validations; collaborate on complete protocols and write reports for gauge R&R analysis.
Assist in developing risk-based assessments to determine inspection requirements and acceptance criteria.
Support internal and external audits and regulatory inspections.
Support product release initiatives and tasks as needed.
Perform other duties as required.