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QA/RA Manager


Real Staffing Brussels (International)

2020-10-20 13:01:31

Job location Aiseau-Presles, Hainaut, Belgium

Job type: fulltime

Job industry: Consulting & Corporate Strategy

Job description

Real Staffing KEY RESPONSIBILITIES Overseeing the implementation of a Quality Plan, Quality Management System, Quality Management Policy, Quality Goals, and applicable regulations and internal standards Assure site and business is properly prepared for external and internal compliance inspections/audit Identify and report any quality or compliance concerns and take immediate corrective action as required Having the authority to issue concessions, stop production, make decisions about people and budget accountability Assure business goals are established and met for compliance, training, CAPA, complaints and production process control across sites/regions. Maintains product quality by enforcing quality assurance policies & procedures and industry requirements; collaborating with other members of management to develop new product and engineering designs. Lead team to design, implement, and improve Supplier Quality processes ensuring Supplier Quality compliance to the QMS, regulatory requirements and overall process improvement. Develop & implement effective regulatory strategies, programs and processes to meet business objectives and ensure compliance with regulatory requirements Lead and support improvement activities, including such areas as regulatory procedure development and documentation, standards compliance, and metrics development and implementation. Liaise with external regulatory bodies to guide input into regulatory strategies Educate, train, & advise company professionals to ensure compliance with RA requirements. As appropriate, recruit, mentor, coach & train direct and indirect reports on activities within areas of responsibility Job description Proven application of analytical skills in a regulatory environment Demonstrated knowledge of regulatory issues, and experience interfacing with local & international regulatory bodies, such as FDA, European competent authorities & notified bodies, Health Canada, etc. Demonstrated project management skills: ability to prioritize, plan, evaluate & execute deliverables for established tactical goals Ability to influence and make recommendations at multiple levels of the company Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer's requirements. REQUIRED QUALIFICATIONS Bachelor's...

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