Quality Systems Manager (Medical Devices)

Location: Plymouth, Minnesota, United States; onsite 5 days per week

Salary: $120,000–$180,000 USD annually, plus short-term incentive eligibility

Company

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

What you will do

• Lead the Quality Management System for the Nathan Lane manufacturing site.
• Oversee quality programs, processes, procedures, and compliance with internal and external standards.
• Lead audit and inspection preparation, finding resolution, and communication with auditors and inspectors.
• Drive continuous improvement across CAPA, document control, training, management review, and quality metrics.
• Partner with Operations, Manufacturing Engineering, Supply Chain, Regulatory Affairs, and other stakeholders.
• Coordinate documentation and legal requests related to government investigations or litigation.

Requirements

• Bachelor’s degree with at least 5 years of relevant experience, or an advanced degree with at least 3 years of relevant experience.
• Experience supporting QMS processes in a manufacturing or other regulated environment.
• Experience with audits or inspections, including FDA, ISO 13485, MDSAP, customer, or internal quality audits.
• Experience interpreting FDA Quality System Regulation, ISO 13485, MDSAP, or comparable requirements.
• Unrestricted U.S. work authorization is required at hiring and throughout employment; sponsorship is not available for this 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

• Degree in Engineering, Quality, Life Sciences, or a related technical field.
• Experience with quality system metrics and continuous improvement projects.
• ASQ certification such as CQE, CQA, or CMQ/OE.

Culture & Benefits

• Onsite collaboration and professional growth within a cross-functional manufacturing organization.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible regular employees.
• 401(k) plan with employer contribution and match, paid time off, and paid holidays.
• Tuition assistance, employee stock purchase plan, employee assistance program, and incentive plans.