Description

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.<div><div><div><div>We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!</div></div></div></div>Position Overview: The Senior Quality Engineer is responsible for ensuring new and existing products conform to the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971. He/she is responsible for maintaining a strong collaborative partnership with cross-functional team members. He/she will serve as a Quality representative to improve awareness, visibility, and communication on all quality initiatives in order to support departmental, functional and corporate quality goals and priorities. He/she can effectively communicate with all levels of the organization. Responsibilities: • Ensures new product introduction quality deliverables are created and properly executed (e.g. Project Quality Plan and Risk Management Plan). • Works with teams to establish measurable, valid product requirements. • Supports Risk Management activities from product Concept through Commercialization. • Supports DHF content completion, integrity, and regulatory and standards compliance. Identifies gaps, collaboratively communicates and works with team to resolve gaps. • Review and approve design control documentation (e.g. plans, protocols, reports) ensuring compliance with the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971. • Provide guidance as needed to assure country specific compliance to the laws and regulations of the targeted market for distribution. • Supports manufacturing process development & qualification for new product commercialization and product changes. • Provides project direction, coaching, and mentoring for engineering and technical team personnel. • Apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues. • Performs other duties as required. 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 ETO sterilization methods preferred. • Experience with methods and standards for the design, verification, and validation of medical device products. • Experience with statistical methods (e.g. statistical process control, sampling plans, gauge R&R, and design of experiments). • 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.

Sr Quality Assurance Engineer

Description

Insulet

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