Quality Sustaining Engineer (MedTech)

TL;DR

Quality Sustaining Engineer (MedTech): Ensuring Healthmark products across hirify.global’s Infection Control Consumables portfolio meet quality requirements with an accent on FDA and EU MDR compliance. Focus on managing design change transfer deliverables, implementing risk management via PFMEA, and leading root cause analysis for product complaints.

Location: Hybrid in Fraser, MI, US (Up to 3 days in office)

Salary: $75,280–$94,100 + 4% STIP

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows across intensive care and sterile reprocessing.

What you will do

• Support design change transfer deliverables according to FDA (21 CFR Part 820 / QMSR) and EU MDR (2017/745) requirements.
• Ensure critical-to-quality (CTQ) attributes are integrated into acceptance activities, equipment qualification, and process controls.
• Lead cause-identification and problem-resolution for quality, production, and service-related issues, including product complaints.
• Act as a subject-matter expert for PFMEA and production-related risk management files per ISO 14971:2019.
• Develop and review production process work instructions and support internal/external audits.
• Implement measurement systems and trending to monitor the effectiveness of quality and reliability systems.

Requirements

• Bachelor’s degree in science, engineering, or a related technical field.
• 5+ years of relevant experience in the medical device industry, including Quality Engineering or Manufacturing Quality.
• Applied knowledge of ISO 13485:2016, ISO 14971:2019, 21 CFR 820 QSMR, and EU MDR 2017/745.
• Familiarity with Geometric Dimensioning and Tolerancing (GD&T) and Statistical Process Control (SPC).
• Must be based in or able to work in Fraser, MI to support a hybrid schedule.
• Strong leadership and communication skills to engage effectively across all organizational levels.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance benefits.
• 401k plan with company match.
• Paid Time Off and Parental/Caregiver Leave.
• Wellness initiatives and Health Assistance Resources.
• Tuition Reimbursement and Commuter Benefits.