Our client is a global early stage medical device company that integrates five separate devices into one unified respiratory system. They offer an excellent career track, benefits, and relocation assistance. This position is based in Kokomo, Indiana.
If you have a Bachelors degree in Engineering, biotech, life sciences or quality and 10 years of experience in Quality Assurance or Quality Management in a manufacturing environment, please send your resume to [email protected] .
Key responsibilities include:
- Reports directly to COO. Supervises, trains, and assists all quality team personnel. Directs quality-related activities in conjunction with Manufacturing, Engineering, Supply Chain, Customer Service, and any other department/function that affects the quality of the organization’s goods or services.
- Establishes policy and provides oversight for staffing, training, and supervision of Quality team members. Assists direct reports in the recruitment and training of personnel.
- Partners with senior management, R&D, Manufacturing, and Operations management teams to establish strategic plans, identify responsibilities, and organize schedules for the transfer and ongoing management of product to manufacturing including: materials purchase, process development, prototype manufacture, QC requirements, sterility studies, equipment development, scale-up, etc. Monitors company performance against the established plan.
- Responsible for the development, implementation, and strict adherence to a quality program in support of FDA cGMP’s and ISO 13485. Develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the production of all products. The Director of Quality has the ultimate authority and decision over the shipment of any product or products and accepts the responsibility for products being in compliance with all regulatory and company standards.
- Reviews and resolves quality control problems/concerns with the Quality Control Manager and others including suppliers, vendors, customers, quality control personnel, and any personnel related to production. Coordinates and assists with vendor inspections.
- Periodically inspects completed quality control checklists, forms, and other documents; randomly inspects and verifies quality control checks for conformance to prescribed standards.
- Schedules and performs quality audits and reports findings to the CEO and other division leaders; develops corrective action plans and ensures timely resolution of findings.
- Prepares reports and other documentation required by regulatory agencies and to support the quality function.
Key qualifications and experience include:
- Bachelor’s degree in engineering, biotech, life sciences, or quality is required
- MBA or Master’s degree in a relevant field of science (e.g., bioengineering degree for a bioengineering company) is preferred.
- 10 years of experience in Quality Assurance/Quality Management in a manufacturing, preferably medical device or highly regulated industry including FDA, CFR and ISO compliance
- Lean or Six Sigma expert; or ability to demonstrate strong foundation in process improvement fundamentals
- Must have proven ability to lead a diverse team of technicians and engineers.
- The ideal candidate is certified in one or more quality-related disciplines (e.g., CQA, CMQ/OE, PMP)