Senior Quality Engineer (Medtech)

TL;DR

Senior Quality Engineer (Medtech): Supporting the Surgical Sutures’ Manufacturing business within hirify.global’s Surgical Innovations group with an accent on ensuring the highest standards of quality and compliance in medical device manufacturing processes. Focus on enhancing product reliability, optimizing processes, and upholding regulatory compliance.

Location: 100% onsite at our North Haven, CT manufacturing site

Salary: $98,400.00 - $147,600.00

Company

hirify.global leads global healthcare technology and boldly attacks the most challenging health problems facing humanity by searching out and finding solutions.

What you will do

• Develop and maintain quality standards and protocols for processing materials into finished products.
• Collaborate with engineering and manufacturing to ensure quality standards are in place.
• Devise and implement methods for inspecting, testing, and evaluating the accuracy of products and equipment.
• Design or specify inspection and testing mechanisms and equipment.
• Conduct quality assurance tests and perform statistical analysis.
• Ensure corrective measures meet reliability standards and documentation is compliant.

Requirements

• Bachelor’s Degree in Engineering, Science, or a technical field with 4+ years of experience in Engineering and/or Quality, or an advanced degree with 2+ years of experience, or a PhD with 0 years of relevant experience.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• Must have unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice to have

• Bachelor’s degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline); advanced degree preferred.
• Strong expertise in process validation across the full validation lifecycle.
• Proven experience leading root cause investigations, CAPA development, and management of nonconforming material (NCMR) activities.
• Proficiency in statistical analysis and tools (e.g., Minitab).
• Experience in FDA-regulated manufacturing (medical device and/or pharmaceutical).

Culture & Benefits

• Competitive salary and flexible benefits package.
• Health, dental, and vision insurance.
• 401(k) plan plus employer contribution and match.
• Paid time off and paid holidays.
• Employee Stock Purchase Plan.