Senior Quality Engineer - North Haven, CT

Location: North Haven, Connecticut, United States; onsite five days per week at the manufacturing facility

Salary: $98,400–$147,600 per year

Company

hirify.global develops and manufactures healthcare technologies, including surgical suture products used in medical procedures worldwide.

What you will do

• Lead process validation across planning, protocol development, execution, analysis, reporting, and ongoing monitoring.
• Partner with manufacturing and engineering teams to establish quality standards, controls, and process requirements.
• Drive root cause investigations, CAPA, and nonconforming material activities.
• Analyze quality and process data using statistical methods to support risk-based decisions and continuous improvement.
• Develop inspection, testing, and evaluation methods and support equipment, process, and test-method qualification.
• Provide technical leadership and mentorship on complex quality and validation projects.

Requirements

• Bachelor’s degree in engineering, science, or a technical field with 4+ years of engineering or quality experience; or a master’s degree with 2+ years; or a PhD.
• At least 2 years of experience executing process validation across the full validation lifecycle.
• Experience supporting compliant manufacturing processes and quality systems in a regulated environment.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for this Senior-level role.
• Work must be performed onsite in North Haven five days per week.

Nice to have

• Experience in FDA-regulated medical device or pharmaceutical manufacturing.
• Experience with Minitab or similar statistical analysis tools.
• Knowledge of CFR requirements, engineering drawings, machining, chemical processing, packaging, or sterilization.
• ASQ Certified Quality Engineer, Lean Six Sigma, or similar certification.
• Degree in chemical, biomedical, or mechanical engineering; an advanced degree is preferred.

Culture & Benefits

• Regular full-time employment with health, dental, and vision insurance.
• Health Savings Account, Flexible Spending Account, life insurance, and disability coverage.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, tuition assistance, and employee stock purchase opportunities.
• Short-term incentive eligibility through the hirify.global Incentive Plan.