The Client is a global medical device and diagnostics company with a broad portfolio of products and solutions. They are the industry leader in blood management solutions.
As Director of Quality Systems you will direct: CAPA, Complaints, Environmental Programs, Sterilization, Management Review, Change Control and Design Review. You will play a cross-functional role working side by side with Manufacturing, Quality Engineering and Software Solutions Quality. Maintain alignment of the Quality System in support of the Company's business goals.
- Implementation and maintenance for Quality System and compliance program requirements- MDD 93/42/EEC, ISO13485, CMDR
- Align Quality strategy throughout the region
- Provide Management with evaluation of overall Quality and Regulatory performance and provide guidance
- Proactively identify and resolve quality issues and ensure compliance to written specifications.
- Develop Quality Systems professional develop in Quality and Regulatory
- Educate employees on Quality Systems regulations.
- Main representative in 2nd and 3rd party quality system audits and investigations- FDA, ISO, Customer, Contractor
- Develop and implement effective CAPA and Continuous Improvement programs using Six Sigma and Lean tools/programs
- Bachelor's Degree- engineering, life sciences or business
- 10+ years Quality Assurance experience
- 7+ years Management experience
- Strong knowledge of ISO-13485, EEC, CMDR
- Strong knowledge of Six Sigma and/or Lean
- Strong Communicator