Site Quality Manager
Site Quality Manager
The DAVIS Companies is supporting a global leader in the medical device industry by securing a Site Quality Manager for their team in the NW Metro. This is an incredible opportunity to be a part of growing organization!
Position Summary of Site Quality Manager:
- Responsible for ensuring that all departments within a plant where devices are assembled/packaged (Finished Product) comply with applicable regulations, licensing and cGMP practices of the US Food and Drug Administration, European Union and other global competent authorities.
- Manages all activities and personnel (directly or indirectly) for handling Finished Product from receiving to commercial distribution as well as assessing and ensuring compliance through training, auditing, corrective and preventive actions.
- Drive continuous improvement through the development and implementation of Quality processes, systems, tools and techniques and provide exceptional support to customers, team members, and shareholders.
Responsibilities of Site Quality Manager:
- Lead the Quality Assurance Department in operating with a high level of efficiency, integrity and enthusiasm, striving to achieve excellence in all endeavors.
- As a member of the site Management Team, be a creative and proactive contributor to bolster process & quality continuous improvement.
- Participates as a Program Management team member to ensure that New Product Introduction and Advanced Quality Planning is performed and customer and regulatory requirements are transferred into issued documentation for use in production
- Oversees the effectiveness of up front quality planning for new products to ensure appropriate quality systems and processes required to support the introduction are developed and implemented.
- Manages statistical analysis projects to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Manages and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Monitor the product acceptance levels (yields) as seen by the customer and ensure that appropriate preventive measures are taken.
- Maintain plant Master Validation Plan (MVP), as needed, for product that will be used in an FDA regulated market. Ensure conformity of initial and ongoing validations performed in support of the GMP quality systems.
- Generate and maintain applicable quality system documentation, as needed. Documents such as Device Master Record (DMR), Design History File (DHF), validation protocols, for example, and other specified documents in support of customer projects.
- Trains or manages training to ensure that personnel engaged in the receipt, manufacture, processing, packing and holding of Finished Product and their components have the education, training and experience to perform their assigned functions.
- Ensures that medical devices and associated packaging materials as well as work-in-process (WIP) and Finished Product are stored in a secure location under conditions appropriate to the product.
- With the support of the plant management, ensures that the facility and equipment used for manufacture, testing and packaging of Finished Product is of the appropriate design, adequate size and location for the intended use and are cleaned and maintained to prevent contamination and mix-up.
- Ensures that the cleaning and environmental monitoring is appropriate to the product including cleaning validation, viables monitoring, pyrogen, bioburden or other required testing.
- Ensures that components, WIP, and Finished Product are inspected according to all requirements, batch records are reviewed and approved by Quality prior to release, and that, if errors have occurred, the errors have been fully investigated
- Ensures that Quality reviews and approves all documents that impact the identity, strength, quality and purity of the Finished Product and that documentation is in compliance with relevant regulatory requirements.
- Ensures that suppliers and contractors are appropriately approved.
- Audits or manages additional auditors to assess compliance to Finished Product and regulatory requirements.
- Assists Quality Engineers, Engineering and Operations staff in developing quality plans, inspection work instructions and procedures, equipment operation documents and any other documents required for batch records and product release.
- Ensures that all plant licenses and registrations are maintained and current.
- Participates in corrective action investigations associated with Finished Product and ensures that true root cause and effective corrective action is enacted.
- Assists in the resolution of customer complaints with the assistance of assigned quality, operations, and engineering personnel.
- Drive continuous improvement through trend reporting analysis and metrics management.
- Serve as Management Representative for the site Quality Management System.
Requirements of Site Quality Manager:
- MS or BS Degree in a related field of study such as Biology, Microbiology, Biochemistry, Engineering, or other science / technical-related fied of study
- Minimum of 10 years of experience in Quality Assurance / Quality Control / Regulatory Compliance with at least 7 years of medical device industry experience in a plant quality operations or related role. Experience in medical device reprocessing quality operations desireable.
- Minimum of 5 years in a managerial / supervisory role with a combination of professional (technical and regulatory) and non-professionals
- Experience with Class I, Class II and/or Class III medical devices is disirable
- Minimum of 5 years of team participation with a demonstrated progression of complexity of assignment and independence
- Professional certifications preferred: CQM/OE, CQE, CQA, ISO Lead Auditor, CSSBB
- Excellent verbal and written communications skills
- Ability to solve problems at an operational and strategic level, manage multiple priorities and conduct data analysis. Working knowledge of FDA GMPs and ISO 13485.