Sr. Quality Sustaining Engineer

Getinge•Fraser, MI

8d•$96,000 - $120,000•Hybrid

About The Position

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.

Requirements

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.
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 regulations applicable to medical devices and combination products.
Familiarity with Geometric Dimensioning and Tolerancing (GD&T) standards and principles.
Experience in Statistical Process Control’s (SPC), data analysis, and trending.
Ability to apply practical and technical problem solving to quality system and product improvements.
Excellent interpersonal skills, including ability to work effectively cross-culturally and cross-functionally.
Proven ability to effectively lead cross-functional team meetings
Capable of developing matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives.
Champions high quality deliverables, innovation, and appropriate risk-based decision making.
Ability to understand the sensitivities within the Getinge’s environment.
Excellent project management and interpersonal skills.
Adaptable to changes in work environment.
Ability to work in a fast-paced environment.
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
Attend all required Quality & Compliance training at the specified interval.
Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Nice To Haves

Advanced degree preferred
May work extended hours during peak business cycles

Responsibilities

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