Senior Principal Quality Engineer (Medical Devices)

Location: Oakdale, Minnesota, United States; minimum of 3 days per week onsite

Salary: $120,000–$165,000 annually, with potential discretionary bonuses

Company

hirify.global develops vital organ therapies, digital solutions, and advanced services, with a focus on improving kidney care and dialysis experiences.

What you will do

• Serve as the primary Quality Subject Matter Expert for drug product and medical device activities at the Oakdale laboratories.
• Establish local procedures aligned with international regulations, including EU MDR, and monitor compliance with the hirify.global Quality Management System.
• Review and approve validation protocols and reports, equipment qualifications, studies, procedures, training plans, change controls, and laboratory investigations.
• Develop audit plans, conduct internal audits, and support external audits involving regulated R&D activities, including EU GMP audits.
• Perform nonconformance investigations and manage Corrective and Preventive Action activities.
• Harmonize laboratory quality practices, procedures, and training with other R&D sites.

Requirements

• Bachelor’s degree in a related field and 6+ years of relevant experience in medical devices, pharmaceuticals, or a similarly regulated industry.
• 5+ years of experience working in or supporting an analytical chemistry or microbiology laboratory for regulated products.
• Familiarity with standard laboratory procedures and GLP/GMP regulations.
• Understanding of Quality Engineering principles and worldwide Quality System standards and regulations.
• Ability to work independently, communicate effectively, make decisions, and promote QMS compliance.
• Ability to work onsite in Oakdale, Minnesota at least 3 days per week.

Nice to have

• Experience with EU GMP, EudraLex Volume 4, ISO 13485, ISP, and USP guidelines and standards.
• Formal audit training or certification, ASQ certification such as CQE or CQA, and/or Six Sigma certification.
• Experience with risk management techniques, test method development, and validation.
• Strong analytical, problem-solving, communication, and cross-functional collaboration skills.
• Ability to manage multiple parallel projects under deadlines and changing priorities.

Culture & Benefits

• Flexible workplace policy with a minimum of 3 onsite days per week to support in-person collaboration.
• Medical, dental, and vision coverage beginning on day one for eligible roles.
• Life, accident, short- and long-term disability, and business travel accident insurance.
• 401(k) retirement savings plan, investment resources, and financial education.
• Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
• Educational assistance, commuting and childcare benefits, an employee discount program, and an Employee Assistance Program.