Plant Quality Manager
Greater Midway, Michigan Area
The Plant Quality Manager will be accountable to ensure the Quality Management System (QMS) is implemented per requirements and to report areas of concern to Management. The Plant Quality Manager will be expected to ensure the plant remains in full compliance will regulatory requirements and ISO requirements as they pertain to the plant, customer specifications, supplier qualifications and corporate quality procedures. Experience with ISO13485 and or ISO9001 is a MUST.
The Quality Manager will Lead the following initiatives:
- Implementation and oversight of a Quality Management system that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including: implementation of document control and review/approval of controlled documents, implementation of change management and review of all change controls, implementation of supplier quality management and performance of supplier audits as appropriate, compliant management including robust root cause analysis and CAPA, implementation of effective Internal Audit Program, ensure adequate Training Program is in place, implementation of an applicable Validation Master Plan including equipment, process, product, sterilization and test methods, implementation and oversight of quality control laboratory and review/approval of QC testing, oversight of cleanroom practices including qualification, monitoring and behavior, implementation of Quality Risk Management in relevant aspects of the QMS, responsible for implementation of the Global QMS e-tool at the plant, and support the Worldwide QMS Manager in development and deployment of policies and procedures for elements of the global QMS.
- Oversee Quality Review of batch documentation and testing and determine disposition for all production batches and incoming raw materials. Ensure robust root cause analysis investigation and CAPA for deviations and nonconforming product.
- ustomer Management including facilitate/host customer audits, ensure robust and effective corrective action to customer audit observations, review/approve quality agreements with customers, partner in the resolution of quality issues and requests for information by initiating effective interdepartmental communication, manage ISO certification and maintenance of certification.
- Supplier Quality Management including qualifying, tracking performance and executing supplier audits
- Facilitate management review process including implementation of a metrics control plan to measure and monitor the health of the Quality Management System, Manufacturing System and Supply Chain.
- Execute talent management activities with direct reports, if applicable. Ensure proper performance management, training and development of direct reports.
- A Bachelor’s Degree is required, preferably in Engineering, Supply Chain or Life Sciences
- A Master’s Degree (MBA or equivalent) is preferred
- Minimum of 7-9 years experience in a Quality Function required, preferably within a regulated industry with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device)