Sr. Manager, Quality (Medical Devices)

Location: Plymouth, Minnesota; hybrid workplace with a minimum of 3 days per week onsite across three physical facilities.

Salary: $144,000–$198,000 annually, plus potential discretionary bonuses.

Company

hirify.global develops vital organ therapy solutions, including kidney-care products, digital solutions, and advanced services.

What you will do

• Act as Quality Management Representative for hirify.global's Twin Cities multi-site R&D campus and implement the global Quality Management System.
• Manage local QMS procedures covering Quality, R&D, Regulatory, Facilities, and related functions.
• Lead regulatory compliance, legal manufacturing responsibilities, external inspections, audits, and management reviews.
• Lead NCR and CAPA processes, internal quality assessments, audits, and continuous improvement projects.
• Manage employee qualification and training, including NCR/CAPA ownership, Change Control Record ownership, and TrackWise 8 access administration.
• Manage quality budgets, coach and develop subordinates, and support other hirify.global sites through MDDAP appraisals.

Requirements

• B.S. degree in Engineering or Science.
• 8+ years of experience in Quality, Manufacturing, Engineering, or a related field, including 3–4 years of supervisory experience.
• Knowledge of global regulatory and quality requirements for manufacturing and marketing medical devices.
• Knowledge of ISO 13485, FDA 21 CFR Parts 7, 11, 803, 806, 810, and 820, ISO 14971, MDD 93/42/EEC, and EU MDR 2017/745.
• Strong leadership skills and demonstrated success managing a large global team.
• Strong analytical, problem-solving, verbal, written, interpersonal, influencing, and negotiation skills.
• Experience working with multifunctional global teams and third-party development partners.
• Ability to analyze and solve complex problems through innovative thought and experience.

Culture & Benefits

• Flexible workplace policy with at least three onsite days per week to support in-person collaboration.
• Medical, dental, vision, life, disability, and business travel accident insurance beginning on day one.
• 401(k) retirement plan, financial education, investment options, and educational assistance.
• Paid holidays, 20–35 days of paid time off based on service length, family and medical leave, and paid parental leave.
• Commuting benefits, employee discount program, employee assistance program, and childcare benefits.