Senior Supplier Quality Engineer (Medical Devices)

Location: Remote anywhere within the United States; travel up to 15% required for supplier audits, performance reviews, business meetings, and cross-functional initiatives.

Salary: $99,200–$148,800 per year, plus eligibility for a short-term incentive plan.

Company

hirify.global develops healthcare technologies designed to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

• Manage quality oversight for strategic contract manufacturers, original equipment manufacturers, and designated suppliers.
• Lead supplier quality activities for product and process changes, including risk assessment, qualification, validation, and implementation.
• Monitor supplier performance, identify quality risks and trends, and drive corrective and preventive actions.
• Plan, conduct, and support supplier audits against GMP, quality standards, and regulatory requirements.
• Partner with R&D, Regulatory Affairs, Operations, and Quality teams to ensure supplied components meet finished-device requirements.
• Investigate supplier nonconformances and complaints, support root cause analysis, and maintain receiving inspection and supplier quality documentation.

Requirements

• Bachelor’s degree in engineering, science, or a technical field with 4 years of engineering or quality experience; alternatively, an advanced degree with 2 years of experience or a PhD with no relevant experience.
• Experience with supplier quality systems, supplier qualification, supplier audits, or supplier performance management.
• Experience applying quality system requirements, technical documentation, specifications, and quality standards in a regulated industry.
• Knowledge of ISO 13485, 21 CFR Part 820, GMP, and global medical device regulatory requirements.
• Unrestricted U.S. work authorization is required at hiring and throughout employment; sponsorship is not available for this Senior-level role.
• For degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Experience with medical device contract manufacturers, OEMs, new product development, product transfers, process validation, design transfer, or supplier onboarding.
• Lead Auditor qualification or an ASQ quality certification.
• Experience leading supplier corrective actions, continuous improvement initiatives, and cross-functional quality projects.

Culture & Benefits

• Full-time employee position with health, dental, and vision insurance.
• 401(k) plan with employer contribution and match, paid time off, and paid holidays.
• Health Savings Account, Flexible Spending Account, life insurance, and disability coverage.
• Tuition assistance, employee assistance resources, employee stock purchase plan, and incentive plans.
• Remote work within the United States with periodic business travel.