Quality Manager- Medical Devices - Greenfield
The main scope of this position is to support the Plant Manager of the new establishing plant in Poland in implementing and maintaining the Quality Management System and Plant start up.
Informacje o kliencie
Our client is a global organization operating in the Medical Devices production. Many years of activity and development allowed our client to play a key role in the forefront of companies in this sector. Supporting the further development of the company, we are looking for a candidate who would be interested in taking up long-term cooperation in the newly created position of Quality Manager for Greenfield - New production plant. Role will be located near to Katowice.
Opis stanowiska
- Ensure that product and processes comply with the relevant requirements of the Quality Management System and customer requirements and appropriate standards
- Responsible for continual improvement activities to enhance the Quality Management System
- Management of the Metrology and Validation functions at the site
- Handling of Out Of Specification results
- Solving of internal non-conformities and planned deviations, analyse failure and cooperate with set up of corrective and preventive actions
- Maintain the areas for non-conforming products
- Manage quality metrics including cost of poor quality
- Implement / update procedures to assure compliance with Quality standards, divisional QMS and regulatory requirements
- Maintenance of site internal audit program and vendor audit programs
- Ensure timely closure of all pertinent Quality Management System processes such as Compliant, Non-Conformance, Change Management, CAPA etc.
- Function as the "Authorized Representative" and the "Responsible Person" for the site
- Work with technical staff in performing root cause analysis and implementing corrective and preventive actions to preclude recurrence, develop and improve processes to reduce variability
- Cooperate with technical staff in performing of FMEA
- Cooperate with SCAR handling issued based on NCR reports, improve process for supplier data submission to reduce internal inspections
- Cooperate with dispatch or scrapping of nonconforming products
- Work in compliance with current good manufacturing practice (GMP)
- Provide records in compliance with good documentation practice (GDP)
- Quality trainings organization and management
- Supervisor responsibility for the team
- Management of the Training Function at the site
Profil kandydata
- Higher education + equivalent knowledge and skills gained via work experience; postgraduate qualification in Quality Management nice to have
- Experience with manufacturing processes, injection moulding, automated and manual assembly processes,
- Relevant expirience in Medical Devices, Farmaceutical or ina Automotive Sector (Injection molding - must)
- Interaction with Notified Bodies and Competent Authorities
- Worked on New Product Introductions
- Significant leadership experience
- Professional level of Business English (C1)
- Sense of humour
Oferujemy
- Work in an international organization with a strong market position and high management culture
- Great independence in action and participation in a strategic project
- Attractive salary and bonus system
Please apply via the button on the right side of this job offer.
Job details
Location: Katowice
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
More
Location: Katowice
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
More
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