Sr Quality Assurance Engineer (Onsite - Acton, MA)
Insulet Corporation
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.
Job description
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.
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%.
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.
- 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.
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
- Employee Wellness Programs
Company overview
Insulet Corporation (NASDAQ: PODD) is an innovative medical device company headquartered in Acton, Massachusetts, founded in 2000 with a mission to improve the lives of people with diabetes. The company specializes in developing, manufacturing, and marketing the revolutionary Omnipod Insulin Management System, which provides a unique alternative to traditional insulin delivery methods. The Omnipod system features a tubeless, disposable wearable Pod that delivers up to three days of continuous insulin without the need for needles or tubing. Insulet's flagship product, the Omnipod 5 Automated Insulin Delivery System, integrates with continuous glucose monitors to manage blood sugar levels automatically, eliminating multiple daily injections and fingersticks. With operations spanning 25 countries across North America, Europe, the Middle East, and Asia Pacific, Insulet has established itself as a global leader in diabetes management technology. The company employs between 1,001-5,000 professionals dedicated to advancing diabetes care through innovative medical device solutions.