Director, Supplier Quality Engineering (Medical Devices)

Location: On-site in Chelmsford, Massachusetts; applicants must reside 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, including products for EMS, hospitals, public safety, and military customers.

What you will do

• Lead and develop the global Supplier Quality organization supporting manufacturing sites in the U.S. and China.
• Set the Supplier Quality Management vision, strategy, roadmap, metrics, and continuous improvement priorities.
• Oversee supplier nonconformances, incoming inspection issues, SCARs, root-cause investigations, documentation, validations, and supplier change requests.
• Develop supplier scorecards, business reviews, supplier development initiatives, and processes to reduce supplier-related COPQ.
• Partner with Sourcing, R&D, Quality Assurance, Regulatory Affairs, Operations, and Manufacturing Engineering on supplier qualification, product launches, and engineering changes.
• Ensure supplier compliance and support audits and regulatory inspections.

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.
• Knowledge of FDA QSR, ISO 13485, MDR, and MDSAP requirements.
• ZOLL does not provide immigration-related sponsorship; applicants must not require current or future sponsorship, including H1B, TN, STEM, or OPT sponsorship.

Culture & Benefits

• Work in an innovation-focused, self-motivated, and entrepreneurial environment.
• Contribute to technologies designed to improve outcomes for underserved patients with critical cardiopulmonary conditions.
• Comprehensive benefits plans are available.
• Annual bonus eligibility is provided in accordance with the company bonus plan.