Quality Control Manager – Ben Arous

Description de l’annonce:

German Multinational Company operating in the medical devices field is looking for a Quality Control  Manager:

The Quality Control  Manager will be responsible for coordinating suppliers and verifying quality standards in accordance with the requirements, will be in charge of performing regular supplier audits to ensure compliance with regulatory standards, as well as actively participating in strategic development based on quality control plans and ensure that laboratory procedures, testing and standard operating procedures are conform to industry guidelines and local requirements

Main Responsibilities & Tasks:

• Inspect and verify supplied products for compliance with applicable requirements
• Plan, organize and conduct audits/assessments of supplier’s systems, processes and products
• Work with suppliers to close out any audit findings/ Document and report audit/assessment results
• Manage quality issues in conjunction with key stakeholders, resolving day to day problems
• Ensure effective containment and problem resolution for all non-conformances
• Report and assess status of supplier performance
• Provide education and coaching on quality systems, regulatory compliance issues and company initiatives
• Provide support for product development 
• Develop a budget for the laboratory, maintains control of laboratory costs and train or supervise training of other laboratory staff
• Compile equipment qualification and / or calibration, report and ensure the qualification status of the laboratory
• Compile standard operating procedures and modify them as needed
• Develop and implement GMP related quality management system/ Coordinate and maintain test schedules for the laboratory and set priorities to ensure that deadlines are met
• Execute approved validation studies based on customer requirements and in line with the validation philosophy and globally harmonized test methods
• Ensure that laboratory procedures, testing and standard operating procedures are conform to industry guidelines and local requirements
• Review and approve GMP relevant documents, e.g. raw data and validation protocols / reports
• Identify, respond, investigate, and document deviations from protocols and accepted practices
• Monitor national and international requirements related to validation topics and implement continuous improvement
• Host audits of the laboratory as participant and spokesperson for the laboratory,
• Liaise with global validation team

Qualifications & Skills:

• Bachelor’s degree in a relevant engineering subject
• 5+ years’ experience in a Supplier Quality capacity ideally within the biomedical or pharmaceutical industry
• Certified Quality Auditor  ISO standards
• In depth knowledge of Quality auditing, and regulatory standards
• Good Technical Engineering knowledge, including ability to understand engineering drawing and standards
• Ability to develop realistic work plans, set personal goals that align with company goals
• Well-organized and methodical, with a superb attention to detail
• Ability to prioritize and manage daily assignments
• Excellent written and verbal communications skills to represent the company professionally
• Establish and maintain positive working relationships with all internal and external interfaces
• Fluent in English

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