Senior Quality Assurance Engineer (Medical Devices)

Location: Onsite in Acton, Massachusetts, United States; international travel of approximately 5% required.

Annual base salary: $87,300–$130,950 for U.S.-based positions, plus potential incentive compensation.

Company

hirify.global develops Omnipod wearable insulin delivery systems and other medical device solutions for diabetes care and subcutaneous drug delivery.

What you will do

• Prepare and execute quality deliverables for new product introductions, including project quality plans and design transfer planning.
• Maintain process FMEAs and support manufacturing risk management activities.
• Review and approve process validation and manufacturing engineering plans, protocols, and reports.
• Support process development, qualification, product commercialization, product changes, and manufacturing capacity expansion.
• Use systematic, data-driven problem-solving methods to identify and resolve quality issues.
• Collaborate with global manufacturing sites, engineering, operations, and contract manufacturing partners to deploy process and quality improvements.

Requirements

• Bachelor’s degree in engineering, a technical discipline, or a scientific discipline, or an equivalent combination of education and experience.
• 5–7 years of quality engineering experience in an FDA-regulated environment, preferably medical device manufacturing.
• Experience with QSR Part 820, ISO 13485, ISO 14971, and process validation for complex medical device manufacturing equipment.
• Experience with high-volume, single-use products and preferably automated manufacturing equipment.
• Knowledge of statistical process control, sampling plans, test method validation, gauge R&R, and process capability.
• Strong communication, collaboration, prioritization, documentation, and root cause analysis skills.

Nice to have

• Master’s degree in engineering or a technical or scientific discipline.
• Experience supporting global manufacturing improvements and contract manufacturing partners.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.
• Work across multiple time zones when required, including outside normal working hours.

Hiring process

• The position remains open until filled.
• Applications are submitted online through the hirify.global Careers site.