Sr. Quality Sustaining Engineer

Sr. Quality Sustaining Engineer

Date:
May 28, 2026

Location:

Fraser, MI, US

Remote Work: 1-2 days at home (site based)

Salary Range: $96,000-$120,000 + 5% STIP

As a Senior Quality Sustaining Engineer, you will play a key role in ensuring that Healthmark products across Getinge’s Infection Control Consumables portfolio meet applicable quality and regulatory requirements. This includes FDA Class I and II medical devices, EU MDR Class I devices, and selected non-regulated products.

In this role, you will take ownership of quality engineering activities within the product lifecycle, including design changes, production quality, and post-market support. You will work cross-functionally with Regulatory Affairs, R&D, Manufacturing, and Operations to drive compliant and effective product lifecycle management while independently leading initiatives and contributing to continuous improvement efforts.

• Lead design change transfer deliverables and activities in accordance with FDA Quality System requirements (21 CFR Part 820 / QMSR), EU MDR (2017/745), and applicable internal quality system procedures
• Take ownership of quality engineering deliverables for assigned products or projects, ensuring compliance with regulatory requirements and internal procedures throughout the product lifecycle
• Ensure critical-to-quality (CTQ) attributes are appropriately defined and implemented, and support the development of acceptance activities, equipment qualification, calibration, validation, and production/process controls
• Provide quality engineering leadership and technical input in the design, fabrication, development, installation, validation, and qualification of equipment and processes, including feasibility assessments and documentation
• Lead root cause investigations and resolution of complex quality issues, including product complaints, nonconformances, and production-related issues, ensuring timely and effective corrective actions
• Serve as a Quality subject-matter expert for PFMEA and risk management activities in accordance with ISO 14971:2019, supporting risk-based decision‑making
• Support development, review, and improvement of production process documentation, including work instructions and change control activities
• Support internal and external audits by preparing documentation, providing objective evidence, and participating in audit discussions
• Analyze quality data and trends (e.g., SPC, complaints, nonconformances) to identify improvement opportunities and support data‑driven decision‑making
• Drive and participate in continuous improvement initiatives to enhance product quality, process efficiency, and compliance
• Act as a key quality representative on cross‑functional teams, collaborating with stakeholders to resolve issues and ensure alignment
• Build effective working relationships across functions, leveraging expertise from colleagues to achieve project and quality objectives
• Provide guidance and mentorship to less experienced engineers as needed

• Demonstrated leadership in problem‑solving and driving quality‑related initiatives within cross‑functional teams
• Strong decision‑making and analytical skills, with the ability to apply risk‑based thinking
• Ability to assess the impact of quality decisions on product performance and compliance
• In‑depth knowledge of applicable quality and regulatory standards
• Experience with data analysis, trending, and statistical tools
• Effective communication and interpersonal skills, with the ability to collaborate across organizational levels
• Ability to manage multiple priorities in a fast‑paced environment
• Bachelor’s degree in science, engineering, or other technical areas; or equivalent job experience required. Advanced degree preferred
• 5+ years of relevant experience in the medical device industry; and have several years of experience in Quality Engineering, Product / Manufacturing Quality or a related role within the medical device industry
• Applied knowledge of ISO 13485:2016, ISO 14971:2019, 21 CFR 820 QSMR, and EU Medical Device Regulation 2017/745 (MDR)
• Working knowledge of international standards and…