Design Quality Assurance Engineer (Remote)
Getinge, Fraser, MI, United States
Design Quality Assurance Engineer (Remote)
Date: Apr 14, 2026
Location: Fraser, MI, US
Remote Work: 5 days at home (fully remote)
Salary Range: $75,280-$94,100/annually + 4% STIP
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
Support and govern design and design change activities in accordance with FDA Quality System requirements and applicable internal quality system procedures.
Drive design change reviews to ensure appropriate risk assessments (ISO 14971:2019) are completed, verification and validation activities 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 rationale and objective evidence for design and change decisions.
Contribute to the continuous improvement of design control and change management processes.
Qualifications
Demonstrated leadership, problem‑solving, decision‑making, influencing, facilitation, and communication skills, and ability to engage effectively at all organizational levels.
Ability to assess the impact of quality management strategies on business performance.
In‑depth knowledge of all applicable Quality and Regulatory standards.
Bachelor’s degree in science, engineering, or other technical area; or equivalent experience (advanced degree preferred).
5+ years of relevant experience in the medical device industry, including several years in Design Quality, Quality Engineering, or related role.
Applied knowledge of ISO 13485:2016, ISO 14971:2019, 21 CFR 820, and EU MDR 2017/745.
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 in a mixed portfolio environment of regulated and non‑regulated products.
Ability to apply practical and technical problem‑solving to quality system and product improvements.
Excellent interpersonal skills, including cross‑cultural and cross‑functional collaboration.
Proven ability to lead cross‑functional team meetings and develop matrix relationships with key colleagues.
Champions high quality deliverables, innovation, and appropriate risk‑based decision making.
Adaptability to changes in work environment and ability to work in a fast‑paced environment.
Remote position with 25 % travel as needed.
Quality Requirements
Build quality into all aspects of work by maintaining compliance with all applicable quality requirements.
Ensure compliance with all FDA and worldwide quality & compliance regulations.
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
Ensure 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.
About Us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life‑science institutions with products and solutions aimed at improving clinical results and optimizing workflows.
Benefits
Health, dental, and vision insurance
401(k) plan with company match
Paid time off
Wellness initiative & health assistance resources
Life insurance
Short and long‑term disability benefits
Health and dependent care flexible spending accounts
Parental and caregiver leave
Tuition reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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Date: Apr 14, 2026
Location: Fraser, MI, US
Remote Work: 5 days at home (fully remote)
Salary Range: $75,280-$94,100/annually + 4% STIP
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
Support and govern design and design change activities in accordance with FDA Quality System requirements and applicable internal quality system procedures.
Drive design change reviews to ensure appropriate risk assessments (ISO 14971:2019) are completed, verification and validation activities 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 rationale and objective evidence for design and change decisions.
Contribute to the continuous improvement of design control and change management processes.
Qualifications
Demonstrated leadership, problem‑solving, decision‑making, influencing, facilitation, and communication skills, and ability to engage effectively at all organizational levels.
Ability to assess the impact of quality management strategies on business performance.
In‑depth knowledge of all applicable Quality and Regulatory standards.
Bachelor’s degree in science, engineering, or other technical area; or equivalent experience (advanced degree preferred).
5+ years of relevant experience in the medical device industry, including several years in Design Quality, Quality Engineering, or related role.
Applied knowledge of ISO 13485:2016, ISO 14971:2019, 21 CFR 820, and EU MDR 2017/745.
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 in a mixed portfolio environment of regulated and non‑regulated products.
Ability to apply practical and technical problem‑solving to quality system and product improvements.
Excellent interpersonal skills, including cross‑cultural and cross‑functional collaboration.
Proven ability to lead cross‑functional team meetings and develop matrix relationships with key colleagues.
Champions high quality deliverables, innovation, and appropriate risk‑based decision making.
Adaptability to changes in work environment and ability to work in a fast‑paced environment.
Remote position with 25 % travel as needed.
Quality Requirements
Build quality into all aspects of work by maintaining compliance with all applicable quality requirements.
Ensure compliance with all FDA and worldwide quality & compliance regulations.
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
Ensure 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.
About Us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life‑science institutions with products and solutions aimed at improving clinical results and optimizing workflows.
Benefits
Health, dental, and vision insurance
401(k) plan with company match
Paid time off
Wellness initiative & health assistance resources
Life insurance
Short and long‑term disability benefits
Health and dependent care flexible spending accounts
Parental and caregiver leave
Tuition reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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