Quality Systems Lead: Document Control & Compliance

Intepros; Tempe (AZ); On-site; USD 110,000 - 150,000; Full time

Job summary

IntePros is seeking a Quality Systems Manager in Tempe, AZ for an 18-month contract to lead the development and continuous improvement of document management and controls. The role ensures compliance with cGMP, ISO, and FDA standards, and oversees MasterControl document control systems and change management.

Responsibilities include coordinating review, maintaining records, and driving CAPA actions. Requires a Bachelor’s degree and 8+ years in quality systems within medical device manufacturing.

Qualifications

• Excellent written and verbal communication.
• Strong attention to detail and prioritization.
• Experience with document management systems (e.g., MasterControl) is a plus.

Responsibilities

• Ensure compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
• Schedule and prioritize documentation review to support business needs.
• Oversee electronic document control system and CAPA processes.
• Lead audits and continuous improvement of the DMC area.
• Mentor staff and support changes to batch production records.
• Travel up to 5%.

Skills

Communication skills

Attention to detail

Prioritization

Education

Bachelor's degree in a related field

Tools

Microsoft Office

Job description

IntePros is seeking a Quality Systems Manager in Tempe, AZ for an 18-month contract to lead the development and continuous improvement of document management and controls. The role ensures compliance with cGMP, ISO, and FDA standards, and oversees MasterControl document control systems and change management.

Responsibilities include coordinating review, maintaining records, and driving CAPA actions. Requires a Bachelor’s degree and 8+ years in quality systems within medical device manufacturing.