Sr Quality Assurance Engineer (Onsite)

About the role

Join Insulet as a Senior Design Assurance Engineer and play a key role in bringing innovative medical device products to market while ensuring the highest standards of quality, safety, and regulatory compliance. This position offers the opportunity to work cross-functionally with engineering, manufacturing, and quality teams, leading risk management, design assurance, and product commercialization activities in a highly regulated environment. Ideal for experienced quality professionals with expertise in FDA regulations, ISO 13485, ISO 14971, and medical device development, this role provides the chance to influence product quality, mentor technical teams, and make a meaningful impact on the lives of people living with diabetes.

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 the team to resolve gaps.
• Reviews and approves design control documentation (e.g., plans, protocols, reports) ensuring compliance with the Insulet Quality System, Quality System Regulation, ISO 13485, and ISO 14971.
• Provides guidance to assure country-specific compliance with the laws and regulations of the targeted market for distribution.
• Supports manufacturing process development and qualification for new product commercialization and product changes.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Applies sound, systematic problem-solving methodologies to identify, prioritize, communicate, and drive resolution of quality issues.
• Performs other duties as required.

Requirements

• BS degree in engineering, a technical or scientific discipline, or equivalent combination of education and experience.
• 5+ years’ experience in an FDA-regulated environment.
• Experience in Quality within 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).
• Proficiency with word processing, spreadsheet, and database programs.

Skills

• Effective verbal and written communication skills.
• Strong collaboration and communication with individuals at multiple levels in an organization.
• Ability to organize and judge priorities.
• Strong problem-solving and root cause analysis skills.
• Good technical report writing and presentation skills.
• Ability to generate and maintain organized and accurate records.
• Ability to follow up with task owners to close out open items.

Schedule

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).

Pay

For U.S.-based positions, the annual base salary range for this role is $87,300.00 - $130,950.00. This position may also be eligible for incentive compensation.

Benefits

• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off (PTO).
• Additional employee wellness programs.