Link to apply: https://k7y.pl/s/xOCp6
Job city: Wayne
Type of job: Full Time (Salaried)
MAQUET Holding is looking for a dynamic leader to oversee Global Quality and Quality Compliance. This position is responsible for ensuring the effective establishment and maintenance of quality systems across all MAQUET businesses.
- Develop and implement Quality Policy across all applicable sites worldwide. Monitors the progress of quality integration at the global level. Interacts directly with government agencies for compliance to medical device regulations. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Strong knowledge of 21CFR820, ISO 13485:2003, MDD, CMDR et al. is mandatory.
- Implementation and management of Quality Metrics
- Develop and roll out effective Quality Manual and the implementation of Global Quality Initiatives.
- Demonstrates effective change leadership. Builds strategic partnerships with internal and external executive level management, outside regulatory agencies, customers, and/or suppliers to further organizational objectives.
- Utilizes technical/professional knowledge and skills to establish, interpret and execute company policies and the Quality System.
- Monitors and ensures compliance with company policies and procedures; makes and executes operational decisions with a strategic perspective.
- Responsible for global internal audit system
- A Bachelor?s degree in Engineering, Science or related field is required. A Master?s of Science in Engineering, Science or related field or MBA is preferred. ASQ CMQ/OE (Certified Manager of Quality / Operational Excellence) or CQE (Certified Quality Engineer) is highly desirable.
Experience and Job Skill Requirements:
- A minimum of fifteen or more years of experience in quality assurance, quality engineering or related functions in a FDA regulated industry or ISO certified organization is required.