Senior Design Quality Lead — Medical Devices

Agiliti Health, Inc.; Wauwatosa (WI); On-site; USD 110,000 - 150,000; Full time

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

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.