Director, Supplier Quality Engineering (Medical Devices)

Location: On-site in Chelmsford, Massachusetts; applicants are expected to live within a reasonable commuting distance.

Annual salary: $190,000–$210,000, plus eligibility for an annual bonus.

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions, serving customers in more than 140 countries.

What you will do

• Lead and develop the global Supplier Quality Engineering organization supporting manufacturing sites in the U.S. and China.
• Set the vision, strategy, roadmap, metrics, and continuous-improvement priorities for Supplier Quality Management.
• Resolve incoming inspection issues and supplier nonconformances, including SCARs and root-cause investigations.
• Oversee supplier qualification, documentation, validations, change requests, audits, and performance reviews.
• Partner with Procurement, R&D, Quality Assurance, Regulatory Affairs, Operations, and Manufacturing Engineering on supplier development, NPI, product launches, and engineering changes.
• Improve supplier quality, reduce supplier-related COPQ and production disruptions, and ensure strong audit performance.

Requirements

• Bachelor’s degree in Engineering, Quality, Supply Chain, or a related field; a master’s degree is preferred.
• 10+ years of experience in Supplier Quality or Quality Engineering within regulated manufacturing.
• 5+ years of experience leading Supplier Quality organizations.
• Experience with complex electromechanical products, global suppliers, and medical devices is preferred.
• Working knowledge of FDA QSR, ISO 13485, MDR, and MDSAP compliance requirements.
• hirify.global does not provide immigration-related sponsorship for this role; applicants must not require sponsorship now or in the future.

Culture & Benefits

• Work in a fast-growing organization focused on improving outcomes for patients with critical cardiopulmonary conditions.
• Culture emphasizing innovation, self-motivation, and an entrepreneurial spirit.
• Comprehensive benefits plans.
• Annual bonus eligibility.