Senior Quality Assurance Engineer

Groningen, Netherlands, 40h, hybrid 

Johnson & Johnson Worksense is responsible for finding, engaging, and contracting talent for the Johnson & Johnson contingent workforce.

We are recruiting a Senior Quality Assurance Engineer to join our contingent workforce in Janssen in Groningen for an initial one-year contract.

Senior Quality Assurance Engineer: 

• Administers the change control program and manages local procedures and specifications in the document control system.
• Leads efforts to comply with company policies, procedures, and quality standards; as well as safety and environmental regulations.
• Develops solutions to database problems of advanced scope and complexity.
• Writes and assists others in writing new or updated operating procedures.
• Generates identifies and suggests improvements in significant performance trends. Reports them to management and appropriate cross-functional teams.
• Releases batches once it has been determined that all compliance and procedural requirements have been met.
• Investigates, tracks, and trends customer complaints and provides complaint data for quality reports including annual drug product reviews, and monthly and quarterly complaint reports.
• Supervises external (including DEKRA/FDA) and internal audits (CQA). Addresses audit observations.
• Manages non-conformity.
• Advises, reviews, and approves changes in products/processes or systems, in line with the applicable procedures. Approves all QMS-related procedures and work instructions.
• Assesses and determines specifications for raw and auxiliary materials, processes, semi-finished products, and end products in relation to internal and external quality standards.
• Ensures continuous improvement of the focus area in response to regulatory developments, trends, deviations, or other data-driven inputs.
• Investigates and resolve Corrective and Preventive actions (CAPAs).
• Analyzes and monitors trends in complaints, with which a possible structural deviation can be identified and corrected. Reports trends to stakeholders.
• Reviews and approves prepared complaint reports.
• Ensures the preparation and implementation of the complaint-handling process within AMO Groningen in accordance with JJSV procedures.
• Rolls out Franchise procedures and regulatory standards.
• Manages the quality system. 

To be successful in this role you have:

• Quality Management System experience in Medical Technology 
• Knowledge of regulations (especially QSR, MDSAP, MDD/MDR)
• Quality Metrics and Management Data Reporting experience
• Experience in CAPA
• Experience in training, training metrics
• Documentation Control & Record Management experience 
• Analytical mindset with a pro-active attitude with an affinity for building networks with internal and external stakeholders
• Fluency in Engish

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

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!