MedTech Quality Engineer: Design Control & CAPA

Actalent; Madison (WI); On-site; USD 53,000 - 106,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan - Pre-tax and R

Life Insurance (Voluntary)

Short and long-term disability

HSA

Transportation benefits

PTO / Vacation / Sick Leave

Job summary

Actalent is seeking a Quality Engineer to oversee design control quality for medical devices in Madison, WI. The role collaborates with R&D and regulatory affairs to ensure FDA and ISO compliance across design inputs, outputs, verification, validation and risk management, while supporting the QMS and CAPA processes.

The ideal candidate has 5+ years in medical devices, experience with CAPAs, nonconformance, design verification, and knowledge of ISO and 21 CFR 820; a Bachelor's in Mechanical or

Qualifications

• 5+ years in medical devices quality engineering and design control.
• Experience with CAPA, nonconformance and design verification.
• Knowledge of FDA/ISO regulations and FDA 21 CFR 820.
• Proven root cause analysis and problem solving skills.

Responsibilities

• Oversee design control quality in engineering for medical devices.
• Collaborate with R&D and regulatory affairs to ensure FDA/ISO compliance.
• Support QMS document lifecycle management and CAPA administration.
• Manage audits and drive continuous improvement of quality systems.
• Provide QA support for manufacturing, including in-process validation and nonconformance management.
• Assist with product release and equipment qualifications.

Skills

Quality engineering

Root cause analysis

Design control

Regulatory compliance

CAPA management

Medical devices experience

ISO/21 CFR 820 knowledge

Education

Bachelor's degree in Mechanical or Manufacturing Engineering

Job description

Actalent is seeking a Quality Engineer to oversee design control quality for medical devices in Madison, WI. The role collaborates with R&D and regulatory affairs to ensure FDA and ISO compliance across design inputs, outputs, verification, validation and risk management, while supporting the QMS and CAPA processes.

The ideal candidate has 5+ years in medical devices, experience with CAPAs, nonconformance, design verification, and knowledge of ISO and 21 CFR 820; a Bachelor's in Mechanical or