Sr. Quality Sustaining Engineer (Medtech)

TL;DR

Sr. Quality Sustaining Engineer (Medtech): Ensuring that infection control consumables meet quality and regulatory requirements with an accent on design changes, production quality, and post-market support. Focus on leading root cause investigations, managing risk through PFMEA, and driving continuous improvement in medical device compliance.

Location: Hybrid (Fraser, MI, US) — Must be based in the United States

Salary: $96,000–$120,000 + 5% STIP

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Lead design change transfer activities in accordance with FDA Quality System requirements and EU MDR.
• Own quality engineering deliverables throughout the product lifecycle, including design changes and production quality.
• Define and implement critical-to-quality (CTQ) attributes and support equipment qualification and validation.
• Lead root cause investigations for complex quality issues, product complaints, and nonconformances.
• Serve as a subject-matter expert for PFMEA and risk management activities according to ISO 14971:2019.
• Analyze quality data and trends using SPC to identify improvement opportunities and support data-driven decisions.

Requirements

• Bachelor’s degree in science, engineering, or other technical areas.
• 5+ years of relevant experience in the medical device industry.
• Applied knowledge of ISO 13485:2016, ISO 14971:2019, 21 CFR 820 QSMR, and EU MDR 2017/745.
• Experience with Statistical Process Control (SPC), data analysis, and GD&T standards.
• Ability to work in a hybrid model (up to 3 days in office) in Fraser, MI.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance benefits.
• 401k plan with company match.
• Paid Time Off and wellness initiative resources.
• Parental and Caregiver Leave.
• Tuition Reimbursement and commuter benefits.