Our client, a contract manufacturer for the medical device, defense, and life science markets, has an immediate opening for a Quality Systems Manager. This role will oversee daily document control activities and actively participate in the Internal Auditing program as a primary internal auditor.

Responsibilities:

• Assist in the quality system training for new employees and provide support to other departments for training on changes
• Assure all document control changes are properly communicated, distributed, and controlled
• Collaborate with associated departments in support of process improvement/enhancement activities
• Compile certification documents, perform final packaging/labeling audit, and release product for shipment
• Coordinate document change activity and process changes to prints, procedures, and forms in accordance with established practices and standards
• Liaison with regulatory reporting agencies and environmental consultants
• Monitor applicable quality systems through trending analysis, compiling metrics, and developing reports on a regular basis
• Perform and document customer complaint investigations and assist Quality Manager with findings to assure actions are effective
• Other responsibilities as required

Requirements:

• 10+ years of similar work experience
• Bachelor of Science degree preferred
• Ability to read and interpret engineering drawings
• Detailed understanding of regulatory and compliance protocols for ISO 13485 and cGMP 21 CFR part 820
• Must be able to read, write, and speak English fluently
• Must be capable of developing procedures, work instructions, flow charts, and forms in support of the quality system requirements
• Strong facilitation, communication, and training skills
• Proficiency in the use of computers, specifically the programs associated with Microsoft Office
• Experience with IQMS ERP is a plus