Design Quality Assurance Manager

POSITION SUMMARY

The 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 crossfunctional 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 designforquality, 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 crossfunctional 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, softwareembedded 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 riskbased and evidencedriven decisions.
• Communicate complex quality and regulatory requirements clearly to technical and nontechnical stakeholders.
• Lead and develop highperforming quality teams through coaching, mentoring, and performance feedback.
• Collaborate effectively across R&D, Manufacturing, Operations, and Supplier Quality to achieve shared objectives.
• Influence crossfunctional teams to proactively identify risks and implement effective mitigations.
• Demonstrate strong organizational skills to manage multiple priorities in a fastpaced development environment.
• Champion a culture of continuous improvement, accountability, and patient safety.

DISCLAIMER

This 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.

It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws.In addition, Agiliti will provide reasonable accommodations for qualified individuals with disabilities. Agiliti strictly prohibits any form of retaliation against individuals who make good faith reports of alleged violations of this policy or who cooperate in Agiliti's investigation of such reports. Affirmative Action Policy Statements

You may be required to obtain certain vaccinations, or provide proof of current vaccination status, based on customer and/or company requirements. If vaccination is required, Agiliti will provide specific directions and cover the expense at a participating clinic. Please note, this includes the COVID-19 vaccination.

Agiliti offers a robust suite of benefits for regular, full-time, non-union employees including: health insurance options for Medical, Dental & Vision plans, Short- and Long-Term Disability plans, Flexible Spending Accounts, Health Savings Accounts, Life Insurance Options, Paid Time Off, 401K Saving Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, and wellness programs.

Agiliti is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law.

Agiliti