Sr Quality Assurance Engineer (Onsite - Acton, MA)

Job Summary

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.

This role works closely with manufacturing, engineering, operations, and contract manufacturing partners worldwide, driving process excellence, resolving quality issues through data-driven problem solving, and supporting the commercialization and expansion of high-volume medical device manufacturing.

Responsibilities

• Ensures new product introduction quality deliverables are created and properly executed (e.g. project quality plan and design transfer planning).
• Risk Management activities through maintenance of pFMEA.
• Supports manufacturing process development & qualification for new product commercialization, product changes, and manufacturing capacity expansion efforts.
• Applies sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues.
• Collaborates with manufacturing sites, globally, to rollout manufacturing / quality / process improvements.

Requirements

• BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience.
• Master’s degree in engineering or technical or scientific discipline preferred.
• 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. Preferably automated manufacturing equipment.
• 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).

Qualifications

• Effective verbal and written communication skills.
• Effective collaboration and communication with individuals at multiple levels in an organization.
• Able to organize and judge priorities.
• Able to generate and maintain accurate records.
• Able to follow up with task owners to close out open items.
• Strong problem solving / root cause analysis skills.
• Good verbal (including presentation) and written communication skills, especially technical report writing.
• Able to generate and maintain organized and accurate records.