Quality Systems Analyst

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a Quality Systems Analyst to join our contingent workforce. You will be working in the Mentor Medical Systems Team of J&J in Leiden, the Netherlands. This will be an initial contract opportunity, starting from May 2022 until April 2023, with possibility of extension.

3 days/week on site work in Leiden (NL), 2 days/week remote work. 

Project Scope:

• The Quality Systems Analyst is the NC and CAPA Site Lead.
• The Quality Systems Analyst ensures the continuous education, implementation and improvement of Quality Systems and compliance with QS regulation and ISO within the Leiden facility. 
• The Quality Systems Analyst ensures that the Leiden plant NC and CAPA processes and structure meet all business and regulatory requirements.
• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines.

Your Responsibilities:

• Ensures the overall management and effectiveness of the NC and CAPA processes.
• Represents the site on the worldwide NC and CAPA teams. 
• Works effectively with other NC and CAPA site leaders to ensure consistent systems and processes.
• Organizes and leads the Data Review Board (DRB). 
• Maintains regular interface with management:
• Assists in the development of quality metrics.
• Provides education and training as needed regarding the NC and CAPA processes, including bounding and failure investigation/ problem solving.
• Presents data analysis to the DRB and Management Review, as appropriate. 
• Reports NC and CAPA scorecard results, as needed.
• Ensures 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 J&J Affiliates and/or Regulatory Affairs team.
• Analyses complex statistical methods, quality tools and computer-generated reports to continuously improve process capability. 
• Leads and participates in quality system improvement initiatives. 
• Conducts internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements. 
• Determines root causes of quality issues and develops corrective action and recommendations.   
• Reviews process change recommendations, as appropriate. 
• Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business.
• Ensures quality systems are effectively deployed and performs periodic checks to verify appropriate application. 

Minimum requirements: 

• University / bachelor’s Degree or Equivalent
• Minimum of Lean/Six Sigma Green Belt is desired for this position as is a background in Statistics.
• Able to communicate and write in English.
• Mathematical and analytical thinking skills 
• Minimum of 3 years in a similar environment with medical devices or pharmaceuticals.
• Thorough understanding of medically regulated plant operations including knowledge of industry standards & regulations, processes and practices in a variety of different departments and operations preferred. 
• Experience in dealing with audits preferred (Notified bodies and/or Competent Authorities).
• Ability to maintain accuracy, consistency and quality of documentation and projects.
• Ability to effectively and efficiently develop and/or enhance quality system processes while ensuring compliance to applicable regulatory standards.

If you meet our requirements and are interested in hearing more about our Quality Systems Analyst role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!