Sr Quality Assurance Engineer (Onsite - Acton, MA)
About The Position
The Senior Quality Assurance Engineer is responsible for ensuring quality, compliance, and continuous improvement within the manufacturing of Insulet’s Omnipod medical devices. This role supports new product introductions, manufacturing equipment implementation, process validation, risk management, and global quality improvement initiatives while ensuring compliance with FDA regulations, ISO 13485, and Insulet’s Quality System. Working closely with manufacturing, engineering, operations, and contract manufacturing partners worldwide, the engineer drives process excellence, resolves quality issues through data-driven problem solving, and supports the commercialization and expansion of high-volume medical device manufacturing. The ideal candidate has 5-7 years of quality engineering experience in a regulated medical device environment, strong knowledge of quality standards and validation methods, and excellent collaboration, communication, and root cause analysis skills. The Senior Quality Assurance Engineer role is responsible for supporting manufacturing line/equipment implementation and validation as well as continuous improvement of existing production processes for Insulet’s Omnipod products. The position focuses on driving manufacturing excellence through improved quality and compliance with Insulet Quality System, Quality System Regulation, ISO 13485. Working closely with global manufacturing engineering, operations, contract manufacturers, and other cross-functional teams, the Senior Quality Assurance Engineer will manage Quality Engineering deliverables in collaboration with cross functional partners, globally. The ideal candidate has a strong Quality Engineering background, experience in medical device manufacturing, expertise process improvement, and a passion for solving complex challenges in a highly regulated environment at a global scale.
Requirements
- BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience.
- 5-7 years’ experience in the FDA regulated environment.
- Experience in Quality in an FDA regulated industry.
- Experience with QSR Part 820, ISO 13485 and ISO 14971.
- Experience with high-volume manufacturing single-use products.
- Experience with methods and standards for process validation of complex manufacturing equipment of medical device products.
- Experience with statistical methods (e.g. statistical process control, sampling plans, Test Method Validation, gauge R&R, and capability).
- Experience with word processing, spreadsheet, database programs.
Nice To Haves
- Master’s degree in engineering or technical or scientific discipline preferred.
- Preferably automated manufacturing equipment
Responsibilities
- Ensures new product introduction quality deliverables are created and properly executed (e.g. project quality plan and d esign transfer planning).
- Risk Management activities through maintenance of pFMEA.
- Review and approve process validation and manufacturing engineering documentation (e.g. plans, protocols, reports) ensuring compliance with the Insulet Quality System, Quality System Regulation, ISO 13485.
- Supports manufacturing process development & qualification for new product commercialization, product changes, and manufacturing capacity expansion efforts.
- Apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues.
- Collaborate with manufacturing sites, globally, to rollout manufacturing / quality / process improvements
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
