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.

The Senior Quality Assurance Engineer is responsible for ensuring new and existing products conform to the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971 throughout the design transfer to manufacturing process as well as product lifecycle. 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:
• Establishes quality deliverables and ensure timely execution to support new product introductions as well as design changes to existing products, using project plans.
• Supports Risk Management activities from design to manufacturing risks.
• Supports DMR content completion, integrity, and compliance. Identifies gaps, collaboratively communicates and works with team to resolve gaps.
• Review and approve process validation / verification, engineering studies, project planning documents (e.g. plans, protocols, reports) ensuring compliance with the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971.
• 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.
• Leads process improvement initiatives, CAPAs, Quality Plans, and other projects as required.

Education and Experience:
• 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.

Preffered Qualifications:

• Master’s degree in engineering or technical or scientific discipline preferred.
• Experience with QSR Part 820, ISO 13485 and ISO 14971.
• Experience with ETO sterilization methods preferred.
• Experience with methods and standards for process 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.

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid 

Additional Information:

The US base salary range for this full-time position is $82,300.00 - $123,700.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.