Senior Operations Quality Engineer (Medical Devices)

Location: North Haven, Connecticut, United States; onsite five days per week

Salary: $98,400–$147,600 per year

Company

hirify.global develops healthcare technologies designed to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

• Lead quality engineering initiatives supporting surgical stapling products and manufacturing operations.
• Establish and improve quality standards, controls, inspection, testing, validation, and monitoring strategies.
• Analyze quality, process, and production data to identify trends and drive corrective and preventive actions.
• Lead root cause investigations and verify the effectiveness of corrective actions.
• Support regulatory, internal, and external audit readiness through compliant quality-system execution.
• Provide risk-based quality recommendations, partner with engineering and manufacturing, and mentor quality team members.

Requirements

• Bachelor’s degree with 4+ years of quality, manufacturing, or engineering experience; or a master’s degree with 2+ years of experience; or a PhD.
• Experience supporting quality systems in a regulated manufacturing environment.
• Knowledge of medical-device quality standards such as QSR or ISO 13485 is preferred.
• Experience with process validation, test method validation, equipment qualification, statistical analysis, or corrective and preventive actions is preferred.
• Unrestricted U.S. work authorization is required at hiring and throughout employment; sponsorship is not available for this senior-level role.
• A qualifying degree under 8 C.F.R. § 214.2(h)(4)(iii)(A) is required for baccalaureate degrees earned outside the United States.

Nice to have

• Medical device, pharmaceutical, biotechnology, or other highly regulated industry experience.
• Lean, Six Sigma, ASQ Certified Quality Engineer, or related certification.
• Experience leading continuous improvement projects and collaborating across manufacturing, engineering, and operations.

Culture & Benefits

• Full-time employee position in a purpose-driven healthcare technology organization.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible regular employees.
• 401(k) with employer contribution and match, paid time off, and paid holidays.
• Tuition assistance or reimbursement, employee stock purchase plan, incentive plans, and employee assistance resources.
• Short-term incentive eligibility through the hirify.global Incentive Plan.