Manager, Operations Quality - NPI Programs (Hybrid - Acton)

Location: Acton, Massachusetts, United States. Hybrid role requiring on-site work at the hirify.global office at least 1 day per week; the ideal candidate works in the office at least 4 days per week. Travel up to 10%, including international travel.

Annual base salary: $110,900–$166,325, with potential incentive compensation.

Company

hirify.global develops medical device products for diabetes and other therapeutic applications, including the Omnipod insulin management platform.

What you will do

• Lead Manufacturing Quality and Supplier Quality support across NPI, supplier readiness, pilot manufacturing, clinical builds, and manufacturing transfer.
• Build, manage, and develop a small Operations Quality team with alignment to Global Quality Engineering and Global Supplier Quality.
• Define inspection, testing, incoming quality, supplier release, control plan, and acceptance strategies for development and clinical-stage builds.
• Ensure DHF/DHR compliance, traceability, lot release, supplier documentation, inspection readiness, and quality records for clinical and early production builds.
• Lead root cause investigations, non-conformance disposition, corrective actions, supplier issue resolution, and quality data trending.
• Support risk management, process and equipment validation, supplier process validation, and transition from pilot manufacturing to commercial production.

Requirements

• BS in Engineering or a related technical discipline and 6+ years of experience in quality engineering, manufacturing quality, supplier quality, or operations quality in a regulated industry.
• Experience leading Manufacturing Quality and/or Supplier Quality Engineering activities, NPI programs, pilot operations, supplier readiness, and development builds.
• Knowledge of FDA QSR, ISO 13485, GMP, design controls, DHF/DHR, supplier controls, inspection methods, metrology, and measurement system analysis.
• Experience with equipment, process, inspection method, and supplier process validation, as well as incoming acceptance processes.
• People leadership, cross-functional collaboration, analytical problem-solving, prioritization, and escalation management skills.
• Ability to work in a Class 8 cleanroom environment as needed; medical device experience is strongly preferred.

Culture & Benefits

• Hybrid working arrangement with regular collaboration from the Acton office.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.
• Opportunity to influence next-generation medical device products in a fast-paced innovation environment.

Hiring process

• Apply online through the hirify.global Careers site.
• The posting remains open until the position is filled.