Supplier Quality Engineer (Biotechnology)

Location: Devens, Massachusetts, United States; onsite work required during standard business hours.

Salary: $73,100–$120,200 per year

Company

hirify.global develops tools that enable research in life sciences and clinical diagnostics and support efforts to treat and prevent disease.

What you will do

• Qualify, assess, onboard, and requalify suppliers through capability assessments, audits, and quality evaluations.
• Manage supplier performance, Approved Supplier List maintenance, supplier risks, and development initiatives.
• Lead Supplier Corrective Action Requests, including root-cause analysis, corrective-action verification, and effectiveness monitoring.
• Conduct supplier and internal audits against ISO 13485, ISO 9001, MDSAP, and applicable regulatory requirements.
• Support CAPA, nonconforming material investigations, complaint investigations, quality risk assessments, PPAP, and new product introductions.
• Collaborate with Quality, Purchasing, Manufacturing, Engineering, and Supply Chain teams to improve product quality, reduce waste, and strengthen manufacturing processes.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline.
• 2–5 years of experience in Supplier Quality, Quality Engineering, or Process Engineering.
• Experience in a regulated manufacturing environment, preferably in medical devices, IVD, biotechnology, or pharmaceuticals.
• Knowledge of supplier quality systems, root-cause analysis, corrective actions, quality improvement methods, PPAP, FMEA, SPC, and supplier development.
• Working knowledge of cGMP, ISO 13485, and FDA-regulated manufacturing environments.
• Must be authorized to work in the United States without current or future visa sponsorship.

Nice to have

• ASQ CQE, CSQP, Six Sigma Green Belt, or similar quality certification.
• Internal Auditor or Lead Auditor experience.

Culture & Benefits

• Medical, dental, vision, life, disability, pet, legal, and identity-protection insurance benefits starting on day one.
• 401(k), employee stock purchase plan, HSA, FSA, and Dependent Care FSA.
• Mentorship, training and development, tuition reimbursement, and promotional opportunities.
• Paid holidays, paid time off, paid parental leave, and volunteer paid time off.
• Employee resource groups, employee events, charity drives, and a culture focused on empowerment and innovation.
• Work takes place in laboratory and production environments with exposure to chemicals, reagents, and standard laboratory equipment; lifting 5–50 lbs and extended standing, walking, and repetitive tasks are required.