Sr Quality Assurance Engineer

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.

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.