Quality System Manager

Inte Pros 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.

• 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 (Master Control) 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.

• Bachelor's Degree Related field required

• 8+ years related experience required

• 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.

• 5%:
  Up to 13 business days per year

• 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.