Site Quality Manager
Sorry, this particular job is closed. But feel free to fill out a General ApplicationSearch Jobs
Site Quality Manager
Title: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. 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.
- Welder in Alpharetta GA
- Shipping & Receiving in Alpharetta GA
- Mechanical Assembler in Duluth GA
- Manufacturing Engineer in Branford CT
- Purchasing Analyst in Central Manchester CT
- Maintenance Mechanic in Eagan MN
- Piping Designer in Alpharetta GA
- Electrical Controls Engineer in Brooklyn Park MN
- Material Handler in Waltham MA
- Stockroom Attendant 1st Shift in Gainesville GA
- System Engineer in Alpharetta GA
- Inventory Clerk in Los Alamitos CA
- CNC Machinist in Santa Fe Springs CA
- Wiring Technician in Hoschton GA
- Sr Mechanical Engineer in Boston MA
- Customer Support Rep in Los Alamitos CA
- Applications Engineer in Fairburn GA
- Project Manager in Fairburn GA
- NDE Analyst in North Canton OH
- Test Technician-Quality Control in Buford GA
- Press Brake Operator-Night Shift in Alpharetta GA
- Sr Buyers - Medical in Merrimack NH
- Client Services Assistant in Oklahoma City OK
- Administrative Assistant in Norwood MA
- Specimen Technician I in Chantilly VA
- Quality Inspector in Suwanee GA
- Press Brake Operator-Day Shift in Alpharetta GA
- CNC MACHINE OPERATOR – 2nd shift in Central Manchester CT
- Controls Engineer in Covington GA
- Inside Sales Administrative Assistant in Duluth GA
- Electronic Assembler - Soldering Technician in Burnsville MN
- Optical Technician in Franklin MA
- Assembler in Acton MA
- Material Handler (Production) 5-22-19 in Westborough MA
- Light Duty - Warehouse in Suwanee GA
- Multi-Purpose Technician in Flowery Branch GA
- Equipment Operator in Flowery Branch GA
- 1st Shift Machine Operator in Sutton MA
- Packaging technician in Sutton MA
- Process Engineer in Fall River MA
- Solderer Level 3 in Nashua NH
- Training Coordinator in Milford MA
- Lead Process and Quality Engineer in Leominster MA
- Process Engineer in Leominster MA
- Systems Tech in Beverly MA
- Specimen Technician I in Norwood MA
- Assembly Specialist II in Golden CO
- Field Service Technician in North Charleston SC
- Press Brake Operator in Suwanee GA
- CNC Maintenance Machinist in Flowery Branch GA
- Material Handler (Production) 5-15-19 in Westborough MA
- Brake Press Operator in Duluth GA
- Assembly Tech II 2nd shift in Worcester MA
- 1st Shift Shipper in Newton MA
- Material Handler (1st Shift) in Franklin MA
- Office Support Assistant in Norwood MA
- Lab Assistant I in Memphis TN
- Packaging Assembly in Marlborough MA
- AutoCAD Drafter in Conyers GA
- CNC Machinist in Boylston MA
- HR Generalist in Franklin MA
- Machine Operator in Suwanee GA
- Production Coordinator in Lynn MA
- Assembly Specialist II in Sharpsburg PA
- E&I Technician 1st & 2nd shift in South Brunswick NJ
- Maintenance Mechanic 2nd shift in South Brunswick NJ
- CNC Machinist (Weekend Days) in Milford MA
- QC Inspector in Needham Heights MA
- Lab Associate in Norwood MA
- HR Generalist in Ashland MA
- Quality Engineer in Branford CT
- Value Add Welder in Flowery Branch GA
- Pressure Vessel Pre-Fabrication in Flowery Branch GA
- Quality Engineer in Bloomington MN
- Reach-Lift Operator in Jefferson GA
- Equipment Operator in Jefferson GA
- Quality Assurance Specialist in Marlborough MA
- Manufacturing Engineer in Newnan GA
- Inspection Specialist in Worcester MA
- Development Engineering Tech I in Westborough MA
- Export Coordinator in Newton MA
- NDE Specialist in North Canton OH
- Customer Service in Northborough MA
- Shipper-Receiver in Northborough MA
- Customer Order Analyst in North Canton OH
- Test Technician in Acton MA
- Material Handler in Holliston MA
- Maintenance Mechanic in Everett WA
- Test Engineer in Manchester NH
- Second Shift Maintenance Mechanic in Haverhill MA
- Manufacturing Process Specialist - Grinding in North Canton OH
- Field Machine Technician in Suwanee GA
- Electro-Mechanic Technician in Suwanee GA
- CNC Operator (All Shifts) in Ashland MA
- Process Engineer in Olive Branch MS
- Underwriter in Marlborough MA
- Production Supervisor - 2nd shift in Shrewsbury MA
- Collections Specialist in Norwell MA
- Shipper in Waltham MA
- Lab Support Personnel in Memphis TN