Medical Device Quality Engineer - Design Control & CAPA

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

Job summary

Actalent seeks a Quality Engineer in Madison, WI for contract-to-hire engagement focusing on design control for medical devices. You will partner with R&D and regulatory affairs to ensure FDA/ISO compliance across inputs, outputs, verification, validation, and risk management.

The role supports the quality system, CAPA, audits, and manufacturing quality with in-process validation and equipment qualification. Requires 5+ years in medical device quality and ASQ cert preferred.

Qualifications

• 5+ years of experience with medical devices.
• 5+ years with CAPA processes, including investigation and corrective action.
• 5+ years of experience with nonconformance management.
• 5+ years of experience with design verification activities for medical devices.
• Proven experience in quality engineering in a regulated environment.
• Hands-on design control elements: inputs, outputs, verification, validation, risk management.
• Knowledge of FDA 21 CFR 820 and ISO quality systems.
• Experience with CAPA administration and effectiveness checks.
• Experience maintaining design history files and quality records.
• Experience collaborating with R&D, regulatory, and manufacturing.

Responsibilities

• Own and lead design control quality activities for medical device projects.
• Partner with R&D and regulatory to ensure compliance with FDA and ISO regulations.
• Plan, execute, and document design verification and validation activities.
• Lead and maintain design risk management activities and documentation.
• Support and improve the quality management system and document lifecycle management.
• Administer CAPA processes including investigation, root cause analysis, corrective actions, and effectiveness checks.
• Manage internal and external audit activities including preparation, response, and follow-up.
• Provide quality engineering support for manufacturing processes and improvements.
• Lead nonconformance investigations with root cause analysis and disposition.
• Support product release by reviewing quality records for compliance.
• Oversee equipment qualification activities to ensure proper validation and maintenance.
• Collaborate with supplier quality and cross-functional teams to sustain quality.
• Apply root cause analysis to resolve issues and prevent recurrence.
• Maintain design history files and quality records for regulatory compliance.

Skills

Medical devices

CAPA

Nonconformance

Design verification

Quality engineering

Design control

FDA 21 CFR 820

ISO quality systems

Root cause analysis

Documentation

ME/Manufacturing Eng

ASQ cert

Education

Bachelor's in Mechanical Engineering or Manufacturing Engineering

ASQ certification or equivalent

Job description

Actalent seeks a Quality Engineer in Madison, WI for contract-to-hire engagement focusing on design control for medical devices. You will partner with R&D and regulatory affairs to ensure FDA/ISO compliance across inputs, outputs, verification, validation, and risk management.

The role supports the quality system, CAPA, audits, and manufacturing quality with in-process validation and equipment qualification. Requires 5+ years in medical device quality and ASQ cert preferred.