Sr Quality Assurance Engineer (Onsite - Acton, MA)

Location: Onsite in Acton, Massachusetts, United States; on-site office, plant, or lab work required. International travel of approximately 5% is expected, with flexibility across multiple time zones.

Annual base salary: $87,300–$130,950, plus potential incentive compensation.

Company

hirify.global develops medical devices for diabetes management and other therapeutic applications through its Omnipod product platform.

What you will do

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

Requirements

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

Nice to have

• Master’s degree in engineering or a technical or scientific discipline.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.
• Work with global manufacturing and cross-functional teams on regulated medical device production.