POSITION SUMMARYThe Design Quality Assurance Manager provides quality leadership and oversight for medical device design and development activities to ensure compliance with applicable regulatory and quality system requirements. This role partners closely with R&D and cross-functional teams to embed quality, risk management, and patient safety throughout the product lifecycle.
This role will require 30% travel.
PRIMARY OBJECTIVES AND RESPONSIBILITIES- Lead quality oversight for new product development, ensuring compliance with 21 CFR 820.30, ISO 13485, MDSAP, and applicable global regulations.
- Partner with R&D to ensure effective execution of design controls, including design planning, inputs, reviews, verification, validation, transfer, and maintenance of Design History Files (DHF).
- Review and approve design and development documentation to ensure accuracy, completeness, and alignment with regulatory and internal quality requirements.
- Own and govern the risk management process in accordance with ISO 14971, including hazard analysis, FMEA, usability risk, and implementation of risk controls.
- Provide technical leadership in design-for-quality, reliability engineering, human factors engineering, and test method development.
- Ensure design changes follow robust change control processes, including impact assessments and timely updates to documentation.
- Serve as subject matter expert for design controls and risk management during internal and external audits and regulatory inspections.
- Lead, coach, and mentor Design Quality Engineers while fostering strong cross-functional collaboration and a culture of proactive quality and continuous improvement.
QUALIFICATIONS- Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, Chemical, or related discipline) required.
- Advanced degree preferred.
- 5-10 years of experience in medical device quality assurance, quality engineering, or regulatory compliance for FDA Class I and II devices.
- Minimum of 3 years of experience in a Senior or Principal Design Quality role with direct or indirect supervisory responsibility.
- At least 1 year of CAPA ownership experience within a design and development environment.
- Demonstrated expertise in design controls, product development processes, software-embedded medical devices, and risk management.
- Experience working in regulated environments governed by FDA QSR, ISO 13485, MDSAP, and ISO 14971.
- Working knowledge of applicable standards such as IEC 60601, IEC 62366, IEC 62304, and EU MDR.
KNOWLEDGE, SKILLS, AND ABILITIES- Apply expert knowledge of medical device design controls and quality system regulations to guide compliant product development.
- Analyze technical and quality data to support sound risk-based and evidence-driven decisions.
- Communicate complex quality and regulatory requirements clearly to technical and non-technical stakeholders.
- Lead and develop high-performing quality teams through coaching, mentoring, and performance feedback.
- Collaborate effectively across R&D, Manufacturing, Operations, and Supplier Quality to achieve shared objectives.
- Influence cross-functional teams to proactively identify risks and implement effective mitigations.
- Demonstrate strong organizational skills to manage multiple priorities in a fast-paced development environment.
- Champion a culture of continuous improvement, accountability, and patient safety.
DISCLAIMERThis job description in no way states or implies that these are the only duties to be performed by the employee in this position. It is not intended to give all details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department and the company.
Primary Job Location:Milwaukee Design Center
Additional Locations (if applicable):Job Title:Design Quality Assurance Manager
Company:Agiliti
Location City:Wauwatosa
Location State:Wisconsin
