Messina Group is searching for a Quality Engineering Manager to start and grow a Quality Engineering function at our client in Lincolnshire, IL; that is relocating to a brand new state-of-the-art facility. The company manufactures products that serve the medical device, life sciences, and pharmaceuticals industries.
The position is accountable for leading the Quality Control and Quality Assurance functions at the company. The Company is launching a new tubing assembly/fluid handling product line, and the Quality Engineering Manager will lead the efforts to design and implement the necessary quality procedures to support the anticipated rapid growth. This includes being accountable for product quality control and working closely with the Operations teams to ensure products and procedures are executed with the highest integrity and efficiency. This position will also be responsible for planning and executing the company’s quality policies, SOP’s, programs, and initiatives. This role will ensure the company’s ISO 9001:2015 certification is maintained and partake in ISO and customer audits. This position reports directly to the Director of Quality and Marketing.
- Design, document, and implement operational and quality processes for the Company’s new, highly controlled, Tubing Assembly/Fluid Handling business.
- This newly created product line is expected to experience rapid growth, the Quality Manager will play the lead role in ensuring the Operational and Quality infrastructure to support the business is developed and implemented.
- Responsible for maintaining cleanrooms at ISO Class 7 standard with appropriate certifications
- Ensure preventative and corrective maintenance is performed on cleanroom mechanicals and equipment
- Record and maintain regular reporting on key room diagnostics, such as particle counts, humidity, temperature, etc.
- Ensure compliance to Company’s gowning and cleanroom protocols by training cleanroom personnel and reviewing activity
- Ensure production is compliant with product specifications by:
- Reviewing and maintaining production batch records
- Creating and maintaining product Certificates of Compliance, Sterility, and Assurance
- Recording, investigating, and resolving non-conforming product
- Perform and record quality control on incoming raw material
- Perform QC final product release
- Interact with vendors on change control notification and compliance
- Manage, investigate, record, and ensure resolution on all internal and external Corrective And Preventative Actions (CAPAs) and Corrective Protocols And Resolutions (CPARs)
Company Quality System
- Maintain company’s ISO 9001:2015 certification by leading annual review and audits
- Promote a quality mindset across the entire company to guarantee adherence with customer expectations, and champion continuous quality process improvement
- Own all aspects of Company’s Quality Manual, including SOPs, Forms, and Work Instructions and ensure compliance to Company’s Quality System
- Train employees and temporary employees on all relevant SOPs and Work Instructions and ensure training records are maintained.
- Respond to customer quality audits, quality questionnaires, and visits and vendor quality audits
- Train Company’s Quality Internal Auditors and oversee internal audit activity
- Ensure internal and external Corrective and Preventative Action Requests are expedited and followed through
- Manage Quality System to scale for Company’s current and future growth