Senior Quality Systems Manager – Document Control & Compliance

Intepros; Tempe (AZ); On-site; USD 110,000 - 140,000; Full time

Job summary

IntePros is seeking a Quality Systems Manager in Tempe, AZ to lead the development and continuous improvement of document management and controls within a medical device manufacturing setting. The role focuses on cGMP, ISO 13485:2016, and FDA regulations, with responsibility for change control, workflows, and metrics.

The ideal candidate has a Bachelor's degree, 8+ years of related experience, and strong communications skills.

Qualifications

• Bachelor's degree in a related field required.
• 8+ years of related experience required.

Responsibilities

• Ensure compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
• Schedule and prioritize documentation review to support business needs.
• Oversee document workflows, change control, approvals and metrics.
• Maintain MasterControl electronic document management system for fast retrieval.
• Lead audit actions and CAPAs related to Document Management and Control.
• Mentor and develop staff in QMS document control activities.

Skills

Communication skills

Attention to detail

Prioritization

EDMS experience

Regulatory knowledge

Lean Sigma

Microsoft Office

Education

Bachelor's degree or equivalent

Tools

MasterControl

Job description

IntePros is seeking a Quality Systems Manager in Tempe, AZ to lead the development and continuous improvement of document management and controls within a medical device manufacturing setting. The role focuses on cGMP, ISO 13485:2016, and FDA regulations, with responsibility for change control, workflows, and metrics.

The ideal candidate has a Bachelor's degree, 8+ years of related experience, and strong communications skills.