Principal Quality Engineer (Medical Devices)

Location: St Paul, Minnesota, United States. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available.

Salary: $112,000–$154,000 annually, plus potential discretionary bonuses.

Company

hirify.global develops healthcare products and solutions focused on its mission to save and sustain lives.

What you will do

• Lead quality engineering for complex manufacturing, sustaining engineering, new product development, process improvement, and product lifecycle activities.
• Provide technical direction for quality risk assessments, design transfers, process controls, validation strategies, and compliance decisions.
• Lead investigations into nonconforming products, customer complaints, CAPAs, audit observations, supplier issues, and manufacturing deviations.
• Support supplier manufacturing processes, including injection molding validation, capability analysis, tooling changes, process optimization, and continuous improvement.
• Establish quality plans, risk management files, inspection strategies, acceptance criteria, statistical methods, and process monitoring systems.
• Represent Quality in audits and regulatory inspections, lead audit programs, and mentor quality engineers and cross-functional personnel.

Requirements

• Bachelor’s degree in Engineering, Science, or a related technical field.
• 5–8 years of Quality Engineering experience in medical devices, biologics, pharmaceuticals, combination products, or a similarly regulated industry.
• Advanced knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, cGMP, validation, and risk management.
• Experience with CAPA, nonconformance management, change control, supplier quality, complaint handling, auditing, validation, and design controls.
• Experience supporting and improving injection molding manufacturing processes in a regulated environment.
• Ability to lead and influence multifunctional teams, analyze complex risks, and make quality decisions balancing compliance, patient safety, business needs, and product requirements.

Culture & Benefits

• Mission-driven environment focused on saving and sustaining lives.
• Medical and dental coverage beginning on the first day for eligible roles.
• 401(k) retirement savings plan with employee contributions and company matching, plus an employee stock purchase plan.
• Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
• Educational assistance, flexible spending accounts, childcare benefits, commuting benefits, and employee assistance programs.