Design Quality Assurance Engineer (Fraser, MI, US)

Job Overview

As a Design Quality Assurance Engineer, you will play a key role in ensuring that new product design and design changes 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.

You will work cross-functionally with Regulatory Affairs, R&D, Manufacturing, and Operations to support compliant product lifecycle management and change execution, with a strong focus on regulatory impact assessment and design change governance within the Arena PLM system.

Job Responsibilities and Essential Duties:

• Support and govern design and design change activities in accordance with FDA Quality System requirements (21 CFR Part 820 / QMSR) requirements for Class I, II devices, EU MDR (2017/745) requirements for Class I devices, and applicable internal quality system procedures.
• Drive design change reviews to ensure appropriate risk assessments in accordance with ISO 14971: 2019 are completed, required verification and validation activities are defined and executed, and traceability between design inputs and outputs is maintained.
• Define quality requirements and critical to quality (CTQ) attributes for finished goods, components and materials acceptance activities.
• Assess and interpret the regulatory impact of design changes and determine potential impacts to regulatory submissions, technical documentation, labeling, and instructions for use.
• Support product classification and regulatory applicability assessments for FDA Class I and II medical devices, EU MDR Class I devices, and non-regulated infection control consumables.
• Serve as a Quality subject-matter expert for change management within the Arena PLM system by supporting Engineering Change Orders, documentation updates and approvals, and change impact assessments.
• Ensure the completeness, accuracy, and traceability of design history documentation, risk management files, and support verification and validation records.
• Support internal and external audits by providing clear rational and objective evidence for design and change decisions.
• Contribute to the continuous improvement of design control and change management processes.

Required Knowledge, Skills and Abilities:

• Demonstrated leadership, problem-solving, decision-making, influencing, facilitation, and communication skills, with the ability to engage effectively at all organizational levels.
• Must have the ability to assess the impact of quality management strategies on business performance.
• Must have in-depth knowledge of all applicable Quality and Regulatory standards

Minimum Requirements:

• 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 Design Quality, Quality Engineering, 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 supporting design changes across the product lifecycle, hands-on experience with a PLM system (Arena preferred), and comfort working in a mixed portfolio environment that includes both regulated and non-regulated products.
• 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 sensitivity 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.
• The position is remote, with 25% travel as needed.

Quality Requirements:

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.

Environmental/Safety/Physical Work Conditions:

• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles
• This position is remote

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

$75,280-$94,100/annually + 4% STIP