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. 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.

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.

• 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

Education and Experience:

• 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).

• Experience with word processing, spreadsheet, database programs.

Skills/Competencies:

• Effective verbal and written communication skills.

• Effective collaboration and communication with individuals at multiple levels in an organization.

• Ability to organize and judge priorities.

• Ability to generate and maintain accurate records.

• Ability 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.

• Ability to generate and maintain organized and accurate records.

Other Expectations:

• Flexibility in multiple time zones, outside of normal working hours 

• Travel (International) – 5%

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.