This responsibility includes plants and associated warehouses in Asia/Europe. The position requires the candidate to work with Plant QA Heads to design and implement multiple quality assurance and control systems that are compliant with quality standards as well as all applicable Regulatory requirements (eg.FDA/IVDR/WHO). The role has responsibility to implement and sustain continuous improvement programs such as Quality Systems Integration
Responsibilities and Duties
Responsible for implementing and maintaining the effectiveness of the quality system across Manufacturing plants.
Direct the Plant Quality Assurance Organizations in Asia/Europe.
Develop and execute strategies to optimize QA operations, including Quality testing, Quality systems, Compliance and Quality Engineering functions, and make key decisions on product quality and regulatory conformance issues.
Provide Quality Assurance oversight to all functions within the Supply Chain organization
Implement controls to ensure product integrity of released product
Coordinate product quality issue resolution collaborating with all functions.
Monitor complaint trends, identify, communicate and address adverse trends
Work closely with the R&D and Design Quality teams to ensure new product launch planning and successful design transfer process.
Directly responsible for interface with outside Regulatory authorities .
Develop and implement quality objectives
Bachelors Degree Engineering/Science/Life Sciences - Post graduate degree desirable.
Job requires extensive knowledge of Medical Devices and/or IVD manufacturing as well as plant operations/product development, distribution and warehousing.
Experience managing multiple sites in QA capacity is desirable.
Proven track record of results managing FDA and other key Regulatory audits.
Proven track record in driving Continuous Improvement programs.
The Director must have a wide range of business and technical knowledge and the
ability to work and interact with several cultures across various time zones.
Experience managing in an environment with changing priorities
10 years plus experience in QA leadership role
Contact Brenda for more information on this role, firstname.lastname@example.org, 0858723761
Stamp 4 Visa required for role