The Site Quality Manager is responsible for ensuring quality and regulatory compliance of the responsible facility, while driving the development, implementation, and continuous improvement of effective and efficient processes. The Site Quality manager represents company to external agencies and champions the evolution of the quality culture for the site.
Essential Functions: • Direct the Site Quality Management System, fully integrated into the Quality Management System, including cross-functional and site-specific processes. The role is responsible for facility compliance covering voluntary, regulatory and company quality requirements and will champion quality initiatives at all levels of the organization. • 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.) • Oversee all Quality related communications and training requirements for all site employees. • Establish positive relationships with outside agencies. • Partner effectively with Operations, Engineering, Global Supply Chain, and other cross functional departments to ensure quality standards are being met at the site. • 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. • Drive site quality objectives, metrics, reporting and operating mechanisms. • 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.
• Bachelor's degree in Engineering, Medical Device Technology or Scientific Field, and a minimum of 5 years of professional experience and understanding of product development, manufacturing, quality control and servicing in a medical equipment or pharmaceutical industry. Master’s degree preferred.
• Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities, five or more years of management/leadership and development experience preferred.
• Practical and leadership experience with FDA’s Quality System Regulations, ISO9001, ISO13485, Medical Device Directive (MDD) and/or other international quality systems requirements with strong practical production and process controls and design control experience.
• Ability to read, analyze, and interpret business plans, technical drawings, procedures and governmental regulations.
• Effective report, business correspondence, procedure writing skills and strong computer skills.
• Good problem identification, multivariable analysis and creative resolution aptitude.
• Proven process development, project management, Lean, Six Sigma, Statistical Analysis, Quality Auditing skills.
• Ability to lead and develop a team of quality engineers in a fast-paced environment.
• Excellent interpersonal skills (including listening, writing, negotiation, facilitation, attention to details
• ASQ Certified Manager of Quality/Operational Excellence (CMQ/OE), ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), or equivalent preferred.