Quality Systems Analyst

Client

Our client is a leading company in the flied of projectmanagement and engineering of companies from all over the world.

University / bachelor’s Degree or Equivalent.
A minimum of 2 years related experience. Medical device manufacturing experience preferred.
Lean/Six Sigma Green Belt and a background in Statistics.
Able to communicate and have writing skills in English.
Mathematical and analytical thinking skills.
Minimum of 3 years in similar environment with medical device or pharmaceutical.
Thorough understanding of medically regulated plant operations including knowledge of industry standards and regulations.
Experience in dealing with audits preferred (Notified bodies and/or Competent Authorities).
Flexibility, integrity, independency and serve minded.

Ensure the overall management and effectiveness of the NC and CAPA processes.
Work effectively with other NC and CAPA site leaders to ensure consistent systems and processes.
Maintain regular interface with management.
Assist in the development of quality metrics.
Provide education and training as needed regarding the NC and CAPA processes, including bounding and failure investigation/ problem solving.
Ensure compliance of NC process, CAPA process and assigned projects with the FDA Quality System Regulation, ISO13485, MDD, CMDR and other industry standards as applicable.
Provides Regulatory Affairs documents when required by affiliates and/or Regulatory Affairs team.
Lead and participate in quality system improvement initiatives.
Conduct internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements.
Determine root causes of quality issues and develops corrective action and recommendations.