QA Engineer

Job title:

QA Engineer

Company:

Johnson & Johnson

Job description

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 atAs 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.

QualificationsWe would love to hear from you, if you have the following essential requirements:

• HBO education (preferably in the direction of Technology)
• 2-4 years of relevant work experience, preferably in the pharmaceutical or medical-device industry
• Knowledge in GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971
• Quality Assurance Systems (QMS) and relevant work rules and procedures
• MS Office
• Validation of technical systems and processes, and statistics and quality improvement techniques
• Excellent command of Dutch and English language

DE&I StatementFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.

Expected salary

Location

Groningen, Groningen

Job date

Tue, 24 Sep 2024 22:51:50 GMT

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