Immediate direct-hire opening for a Quality Manager in the greater Orlando area. This is a medical device manufacturing company. They would like someone with at least 5 years of professional experience, ideally performing quality control in an environment that manufactures medical devices. specifically performing quality engineering in a manufacturing environment for medical devices. The ideal candidate will also have 3 years of supervisory/management experience and a working knowledge of or practical experience with ISO 9001/ISO 13485. A Bachelors of Science in Engineering (or a related field) is required.
Relocation assistance is available for the right candidate.
Responsibilities for the QA/QC Manager
Requirements for the QA/QC Manager
- Direct the site quality management system, including cross-functional and site-specific processes.
- Maintain and drive improvements to all aspects of site quality planning
- Ensure consistent application of plans and programs to drive compliance for all applicable governmental regulations (ISO13485, FDA, MDD, MHLW, CFDA, KFDA, Health Canada, etc.)
- Ensure site audit readiness and host Quality System audits and inspections
- Oversee the Corrective Action / Preventive Action (CAPA) activities, Supplier Corrective Actions, and Quality Engineering
- Conduct analysis of quality indicators to identify trends, drives and support root cause investigations, and implementation of appropriate corrective actions
- Evaluate staffing needs and costs related to the Plant Quality teams; identify, hire, and promote individuals with the correct skills and competencies to achieve superior results
- Report on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews
- Act as Management Representative for Quality at the Site
- BS in Engineering, Medical Device Technology or Scientific Field required. Master's Degree preferred.
- 5+ years of professional experience and understanding of product development, manufacturing, quality control and servicing in a medical equipment or pharmaceutical industry
- Practical and leadership experience with FDA's Quality System Regulations, ISO9001, ISO13485, Medical Device Directive (MDD) and/or other international quality systems requirements
- Proven process development, project management, Lean, Six Sigma, Statistical Analysis, Quality Auditing skills
- ASQ Certified Manager of Quality/Operational Excellence (CMQ/OE), ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), or equivalent preferred
<Benefits for the QA/QC Manager
- Company sponsored medical benefits + 401K option and PTO