QA Engineer

Johnson & Johnson is currently seeking a QA Engineer to join our Quality Assurance team located in Groningen.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

As a Quality Engineer, you will provide support for product and process development projects and the production process, as well as support in the implementation, improvement and development of the quality policy and the quality system in order to guarantee the quality of the goods produced by AMO Groningen.

What you will be doing:

• Ensure quality assurance within product and process development projects


• Perform and assess statistical analyzes and support the implementation of statistical process control techniques, sampling schemes and other quality techniques


• Assess and partly determine specifications for raw materials and consumables, processes, semi-finished products and end products in relation to internal and external quality standards


• Drafting and reviewing protocols and reports


• Review all changes to product specifications


• Advising, reviewing and approving changes in products/processes or systems, in line with the applicable procedures. Approving all QMS related procedures and work instructions


• Continuous improvement of the focus area in response to regulatory developments, trends, deviations or other data-driven input


• Addressing non-conformities within production and taking care o f internal escalations


• Guiding planned deviations from the production process


• Advsing, reviewing and (approving) changes in production processes, in line with the applicable procedures


• Analyzing data on rejects within the production process for continuous improvement and reducing or eliminating sources of variation within the production process


• Provide support regarding the qualification of equipment/process/computerized systems ensuring that the validation approach, output and documentation comply with applicable procedures.