Supplier Quality Engineer (Medtech)

TL;DR

Supplier Quality Engineer (Medtech): Ensuring the quality and reliability of supplier-provided materials and components for neuroscience and spinal technologies with an accent on supplier qualification and risk-based audits. Focus on monitoring supplier performance, ensuring GMP compliance, and supporting New Product Development (NPD) lifecycles.

Location: Onsite 4 days a week in Boxborough, MA

Salary: $80,000 - $120,000

Company

hirify.global is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Lead supplier qualification activities and execute risk-based audit plans to ensure material reliability.
• Monitor supplier performance from sourcing through manufacturing to resolve quality issues.
• Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
• Support New Product Development (NPD) by partnering with engineering teams for supplier selection and qualification.
• Develop product acceptance sampling strategies and establish control plans for new products.
• Define receiving inspection requirements and validate internal test methods.

Requirements

• Bachelor's degree in Engineering or a Technical field with 2+ years of relevant experience (or an advanced degree).
• Must possess unrestricted U.S. work authorization at the time of hire.
• Ability to work onsite 4 days a week in Boxborough, MA.
• Ability to travel up to 15% for project completion and collaboration.

Nice to have

• Experience with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
• Proficiency in quality engineering tools: CAPA, root cause analysis, statistical techniques, and FMEA.
• ASQ certification (CQE, CSQP) or Lean Six Sigma Green/Black Belt.
• Experience in supplier development within a regulated industry.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and matching.
• Paid time off, paid holidays, and short-term disability.
• Employee Stock Purchase Plan and tuition reimbursement.
• Global well-being program (Simple Steps) and employee assistance program.