Actalent is hiring a Quality Manager!

Job Description

Develop and maintain a quality management system compliant with ISO 13485 and FDA regulations. Conduct both internal and external quality audits and manage the supplier quality system. Lead and develop the quality team to ensure adherence to high standards.

Responsibilities

• Develop and maintain a quality management system compliant with ISO 13485 and FDA regulations.
• Conduct internal and external quality audits.
• Manage the supplier quality system.
• Lead and develop the quality team.

Essential Skills

• Strong knowledge of ISO and FDA regulations for Class III medical devices.
• Experience with FDA inspections and audits.
• Minimum of 5 years in quality management within the medical device industry.
• Minimum of 5 years managing a team.

Additional Skills & Qualifications

• Bachelor's or Master's degree in engineering or a related field.
• Experience with FDA QSR standards.

Work Environment

The role is based in a medical device manufacturing environment in Longmont, CO. The facility includes various clean room setups across multiple buildings within the business unit.