Quality Director EMEA
Due to current structural changes and further development plans, we are looking for a Quality Director whose responsibility will be to manage quality departments both in manufacturing sites and distribution chains across Europe and Americas.
Client Details
Our client is a globally recognized medical device company that develops, manufactures and sells technologically advanced instruments. The company is constantly increasing its global market share by opening new markets and diversifying their business by launching New Products. Due to current structural changes and further development plans, we are looking for a Quality Director whose responsibility will be to manage quality departments both in manufacturing sites and distribution chains across Europe and Americas.
Description
- Implement, maintain and develop Quality Assurance system including: ISO 13485, Part 820, Japanese, Brazilian, Korean, Australian regulations
- Manage product releases and process validation in cooperation with Regulatory Affairs department
- Recommend actions with regards to suppliers' cooperation based on performed audits, risk and compliance assessments
- Perform quality audits and receive incoming inspections and external product and GMP audits
- Implement efficient control frameworks based on Lean philosophy
- Manage quality assurance and quality control teams
- Cooperate with EU and non-EU Authorities
Profile
- Higher Education - chemical, pharmaceutical or microbiological
- Minimum 5 years of experience gained in Pharmaceutical or Medical Device sector
- Minimum 5 years of experience as Quality Assurance Director managing a team of minimum 25 employees
- Experience in quality assurance gained on regional level, knowledge of American standards FDA would be an asset
- Project management skills and proficiency in New Product implementations
- Ability in dealing with ambiguity, and handling multiple priorities simultaneously
- Demonstrated track record in taking initiative, working independently
- Strong proactive approach, marketing acumen, "self-run" person
- Fluency in English
Job Offer
- Excellent working environment with regards to safety and ethics
- Career development opportunities in a company promoting innovative and modern technologies
- Competitive salary
Location: Warsaw
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.
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