Quality Engineer II (Medical Devices)

Location: 100% onsite in North Haven, Connecticut, United States; work is performed five days per week onsite at the manufacturing site. Candidates must have unrestricted U.S. work authorization at hire and throughout employment.

Salary: $79,200–$118,800 USD per year, excluding Puerto Rico and specific California locations.

Company

hirify.global develops healthcare technologies and medical devices focused on improving patient health and extending lives.

What you will do

• Develop, modify, apply, and maintain 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 measures meet reliability standards and that quality documentation complies with requirements.
• Support quality activities across production control, incoming materials, product evaluation, reliability, inventory control, and research and development.

Requirements

• Bachelor’s degree in engineering, science, or a technical field with 4+ years of engineering or quality experience; or an advanced degree with 2+ years of experience; or a PhD with no required relevant experience.
• Experience in engineering and/or quality within a manufacturing environment.
• Unrestricted U.S. work authorization is required; sponsorship is not available for roles below Principal level.
• For degrees earned outside the United States, the degree must meet the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• Strong written and verbal communication skills.

Nice to have

• Engineering degree in chemical, biomedical, mechanical, or a related discipline.
• Process validation experience across the full validation lifecycle, including IQ, OQ, TMV, and PQ.
• CAPA experience.
• Familiarity with Minitab Statistical Software.
• Six Sigma training.

Culture & Benefits

• Collaborative, cross-functional work in a medical device manufacturing environment.
• Health, dental, and vision insurance, plus health and flexible spending accounts.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, disability coverage, life insurance, and employee assistance resources.
• Tuition assistance, incentive plans, employee stock purchase plan, and wellness resources.