Qualifications
Responsibilities
Benefits
Job Summary
The Senior Quality Assurance Engineer is responsible for ensuring the quality, safety, and regulatory compliance of medical device manufacturing processes while serving as a key quality representative for production operations. This role partners closely with manufacturing, engineering, operations, and quality teams to investigate nonconformances, lead root cause analyses, manage CAPAs, support process validations, and drive continuous improvement initiatives that ensure the consistent production of safe and effective medical devices. The position requires strong expertise in quality systems, risk management, statistical analysis, and regulatory standards such as FDA regulations, ISO 13485, and ISO 14971. Expectations include providing day-to-day manufacturing quality support, leading investigations and risk assessments, supporting audits and inspections, reviewing manufacturing documentation, mentoring junior engineers, and driving cross-functional problem-solving efforts while maintaining compliance and improving operational performance. Candidates should have significant quality engineering experience in the medical device industry, excellent analytical and technical writing skills, and the ability to manage multiple priorities in a fast-paced manufacturing environment.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 juniorQuality 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
Bachelor6s degree in engineering (Mechanical, Biomedical, Electrical, Manufacturing, Materials Science, or related discipline) or equivalent combination of education and experience.
Minimum of 5years 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
Additional Information:
Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $87,300.00 - $130,950.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: Medical, dental, and vision insurance 401(k) with company match Paid time off (PTO) And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.About Insulet Corporation
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