Quality Systems Manager

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 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.