Design Quality Assurance Manager

Agiliti Health, Inc.

Wauwatosa (WI)

On-site

USD 110,000 - 150,000

Full time

14 days+

Application generator

A complete application in a minute — tailored resume and cover letter, ready to send.

Get past ATS filters

Benefits offered by this job

Health insurance options for Medical,

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

wellness programs

Job summary

Agiliti is seeking a Design Quality Assurance Manager to lead quality oversight for medical device development and ensure compliance with regulatory and quality systems. The role partners with R&D to embed quality, risk management, and patient safety across the product lifecycle. 30% travel is expected.

The successful candidate will drive design controls, risk management, and audits, coaching-mentoring Design Quality Engineers and collaborating across functions to improve processes and outcomes.

Qualifications

Bachelor's degree in engineering required.
5–10 years in medical device QA or regulatory compliance.
3+ years in Senior/Principal design quality with supervision.
CAPA ownership experience in design and development.
Experience in FDA QSR, ISO 13485, MDSAP, ISO 14971.
Knowledge of IEC 60601, IEC 62366, IEC 62304, EU MDR.

Responsibilities

Lead quality oversight for new product development under 21 CFR 820.30 and ISO 13485.
Partner with R&D to execute design controls: planning, inputs, reviews, verification, validation.
Review and approve design and development docs for regulatory compliance.
Own risk management per ISO 14971: hazard analysis, FMEA, risk controls.
Provide technical leadership in design for quality, reliability, human factors, test methods.
Lead audits and inspections as SME for design controls and risk management.

Skills

Quality leadership

Regulatory compliance

Risk management

Cross-functional teamwork

Design controls

Auditing

Communication

Education

Bachelor's in Engineering

Advanced degree preferred

Job description

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.