Quality Control Manager

Job purpose

The Quality Manager has the overall responsibility and authority to establish and continuously improve EDC's Quality Management System in accordance with the current ISO 9001:2015 Quality Management Systems Requirements. The Quality Manager is also assigned with the responsibility and requisite authority to serve as EDC's ISO Management Representative.

Duties and responsibilities

• Lead the organization to establish and continuously improve the Quality Management System; including certification to the current ISO 9001:2015 Quality Management Systems Requirements across multiple sites.
• Upgrade the organization to ISO 13485:2016 across multiple sites.
• Oversee effective deployment of human resources throughout the department.
• Serve as the ISO Management Representative for the EDC Management Team, including administration of periodic Management Reviews; review and maintenance of the Quality Policy, Quality Manual, QMS Plan and Quality Objectives; and response to external QMS related inquiries.
• Provide quality management support for all QMS processes, with specific oversight and implementation responsibility for Nonconformities, Corrective Actions, Document Control, Internal Auditing, and QC Inspection of Image Bundles and Small Diameter Subassemblies.
• Performs root cause analysis and works with Production Support to prevent manufacturing defects.
• Provide QMS Communication and Awareness training throughout the organization; providing daily direction and guidance as needed to ensure accurate and consistent application of QMS processes.
• Coordinate external audit activities and serve as primary contact for certification and surveillance audits, 3rd party and customer audits.
• Manage customer complaints, establish trending, implement corrective actions and respond appropriately to all investigation requests.
• Reviews daily on-the-floor quality related issues with other applicable department management to determine need for corrective actions.
• Reviews incoming returned product from customers as either nonconforming product or returns for restock.
• Works directly with customers on review of nonconforming product to include issuance and management of corrective actions (8D's), as required, and visits to the customer facilities to report on actions taken to address quality concerns.
• Works with suppliers on incoming product quality issues to include issuance of supplier corrective actions, as necessary.
• Works with R&D to ensure all product specifications are developed for new products and maintained throughout batching process and production for all products.
• Support needs of external customers as needed.

Qualifications

• Minimum of bachelor's degree in relevant business or scientific discipline, or a bachelor's degree and a minimum of four years of related experience
• Prior leadership experience and maintaining an ISO 9001 certified or comparable QMS.
• Working knowledge of 6 Sigma and Lean Methodology
• Working knowledge of process validations
• Possess strong communication and interpersonal skills to address and resolve issues in a positive manner.
• Excellent working knowledge of MS Office products, document control systems and quality management tools.
• Ability to work without being distracted by internal or external influences to effectively execute the above listed duties and responsibilities.

Working conditions

The job is performed at our facility at 14062 Riverport Dr. in a climate controlled non-smoking environment. It requires a person to work a standard day consistent with exempt employee expectations, where occasional extra effort may be needed to support the organization's needs. The position may also require occasional overnight travel.

Current Openings for Quality Control Manager Jobs at Healthcare Components Group