Quality System Manager

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 currently looking for a Quality Systems Manager to join one of our medica device/manufacturing clients in Tempe, AZ. This is a 18 month contract role. The Quality Systems Manager leads the development, effective implementation, and continuous improvement of Document Management and Controls. This includes document changes, and record retention and management.

Quality Systems Manager Responsibilities:

• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
• Schedule and prioritize documentation review to support Business needs.
• Provide document oversight supporting the following areas - nomenclature enforcement, BOM structure, lifecycle status, document workflows, change control processes, approval flows, producing metrics.
• Maintains electronic document control system (MasterControl) to ensure fast retrieval of documents.
• Support update, review and approval of controlled documents, including procedures, work instructions, protocols, templates and technical documents
• Become extremely well versed in the electronic document management system and track trend and monitor metrics related to document management and control, providing reports as necessary.
• Drive continuous improvement to support a sustainable framework for QMS document control activities to enable simplification and standardization.
• Lead and drive audit actions and CAPA's associated with the Document Management and Control.
• Ensures batch production records are in compliance to all internal and external key quality attributes.
• Ensures the document, record and file batch production records on completion.
• Oversee, mentor and develop staff.
• Performs other duties and project as assigned.

Education

• Bachelor's Degree Related field required

Work Experience

• 8+ years related experience required

Quality Systems Manager Preferred Knowledge and Skills:

• Strong written and oral communication skills, attention to detail, and the ability to prioritize.
• Experience with different electronic document management systems.
• Intermediate to advanced working knowledge of medical device regulations and standards (ISO 13485: 2016, cGMP and FDA regulations)
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Intermediate to advanced computer skills and software applications, including experience with Microsoft Office tools (outlook, Word, Excel, Powerpoint)
• Proven ability to prioritize and organize a busy and changing workload.

Travel Requirements

• 5%: Up to 13 business days per year

Physical Requirements

• Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.