Quality Engineer II (Medical Devices)

Location: 100% onsite in North Haven, Connecticut, United States

Salary: $79,200–$118,800 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies and medical devices used to improve patient health worldwide.

What you will do

• Develop, maintain, and apply quality standards and protocols for partially finished and finished products.
• Collaborate with engineering and manufacturing teams to establish and maintain quality standards.
• Design and implement inspection, testing, and evaluation methods for products and production equipment.
• Specify inspection and testing equipment, conduct quality assurance tests, and perform statistical analysis.
• Ensure corrective actions meet reliability standards and that quality documentation complies with applicable requirements.
• Support quality activities across production control, incoming materials, product evaluation, reliability, inventory control, or research and development.

Requirements

• Bachelor’s degree in engineering, science, or a technical field with 4+ years of engineering and/or quality experience; or an advanced degree with 2+ years of relevant experience; or a PhD with no required experience.
• Experience in engineering and/or quality within a manufacturing environment.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment.
• U.S. work authorization sponsorship is not available for this role; sponsorship is limited to Principal-level roles and above.
• International bachelor’s degrees must meet the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Engineering degree in chemical, biomedical, mechanical, or a related discipline; an advanced degree is preferred.
• Experience in a fast-paced manufacturing environment.
• Process validation experience across the full lifecycle, including IQ, OQ, TMV, and PQ.
• CAPA experience and familiarity with Minitab Statistical Software.
• Six Sigma training and strong written and verbal communication skills.

Culture & Benefits

• Five-day onsite work environment supporting professional growth and cross-functional collaboration.
• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Healthcare Flexible Spending Account, life insurance, disability coverage, and dependent-care spending account.
• 401(k) plan with employer contribution and match, paid time off, and paid holidays.
• Tuition assistance or reimbursement, incentive plans, employee stock purchase plan, and employee assistance program.