Supplier Quality Engineer II (Medtech)

TL;DR

Supplier Quality Engineer II (Medtech): Managing supplier quality agreements and ensuring regulatory compliance for medical device components with an accent on ISO13485 standards and GMP. Focus on qualifying suppliers, resolving quality issues, and collaborating with cross-functional teams to prevent defects in new product development.

Location: Must be based in the US, with a preference for candidates near Mansfield, MA or Lafayette, CO.

Salary: $80,000 – $120,000 USD

Company

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

What you will do

• Negotiate, review, and approve Quality Agreements with external suppliers.
• Qualify suppliers according to company standards and monitor performance throughout the manufacturing cycle.
• Develop and execute auditing schedules to ensure compliance with GMP and quality standards.
• Provide quality engineering support for New Product Development (NPD) in partnership with component and post-market teams.
• Collaborate on Product Acceptance Sampling Strategies and Approved Supplier List coordination.
• Define receiving inspection requirements and validate internal test methods.

Requirements

• Must possess unrestricted U.S. work authorization at the time of hire.
• Baccalaureate degree with minimum 2 years of relevant quality experience OR Master's degree with 0 years of experience.
• Strong knowledge of supplier quality requirements and regulatory compliance.
• Ability to interpret quality system requirements and translate them into contractual obligations.
• Excellent written and verbal communication skills for cross-functional collaboration.
• High attention to detail in document review and approval workflows.

Nice to have

• Prior knowledge of ISO13485 standards.
• Experience negotiating and finalizing Quality Agreements with external suppliers.
• Proven experience in risk assessment, issue resolution, and decision-making.

Culture & Benefits

• Comprehensive health, dental, and vision insurance including HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and various incentive plans.
• Global well-being programs and employee assistance services.