Quality Engineer - Investigations

Johnson & Johnson; Leiden; On-site; EUR 34,000 - 69,000; Full time

Job summary

Johnson & Johnson is seeking a Quality Engineer (Investigation Owner) in the Netherlands to lead critical quality investigations and drive process improvements in a pharmaceutical setting.

The role involves identifying root causes, coordinating CAPA and change controls, and ensuring regulatory compliance while collaborating with cross-functional teams. Strong problem-solving and analytical skills are essential for success in this contract position.

Qualifications

• HBO degree with 3–5 years experience in investigations or quality engineering.
• English level at B2 or higher is required.
• Good computer skills: MS Office and data analysis.
• Able to work independently or in a team and handle changing priorities.

Responsibilities

• Lead and manage quality investigations for manufacturing processes, products, and systems.
• Perform non-conformance investigations, CAPA records, and lead change controls from initiation to completion.
• Review documentation for Operations unit and ensure compliant, timely quality records.
• Maintain procedures and documentation updated to regulatory requirements and audits.
• Initiate risk mitigations and continuous quality improvement projects under limited guidance.
• Perform GEMBA walks to observe GMP adherence and drive corrective actions.

Skills

Quality investigations

CAPA

GEMBA walks

Data analysis

Education

HBO degree

Tools

MS Office

Data analysis tools

Job description

Imagine your next project leading critical quality investigations to drive process improvements and ensure regulatory compliance in a dynamic pharmaceutical environment.

The Quality Engineer (Investigation Owner) is responsible for leading and managing quality investigations related to manufacturing processes, products, and systems. This role involves identifying root causes of quality issues, coordinating corrective and preventive actions, and ensuring compliance with internal standards and regulatory requirements. The Quality Engineer works closely with cross-functional teams to document findings, drive process improvements, and communicate results to stakeholders. Strong analytical skills, attention to detail, and effective problem-solving abilities are essential for success in this position.

Experienced individual contributor that executes tasks that are both routine and not routine. Assembles and leads the team required for quality records. Escalates issues and risks as required. Demonstrates effective communication skills. Maintains high standards of professionalism, efficiency, personal communication, discretion, and independent judgment.

roles and responsibilities.

• Applies expertise knowledge of Quality requirements to support the handling of quality records
• Perform non-conformance investigations, including CAPA records and lead change controls (CC) for the operations unit from initiation through completion.
• Reviews documentation associated with processes and activities for the Operations unit products.
• Maintains procedures and applicable documentation and makes updates based on new or revised regulatory requirements, internal investigations, and audits.
• Ensure compliant documentation and timely completion of quality records.
• Initiates and implements risk mitigations and continuous quality improvement projects, under limited guidance.
• Supports with formal escalation processes to ensure visibility of risks associated with safety, product quality and regulatory compliance.
• Perform regular GEMBA walks to observe and document adherence to GMP standards on the production floor, identify areas for improvement, and collaborate with team members to implement corrective actions.

how to succeed.

• A relevant HBO degree with 3 - 5 years relevant experience, in an investigation lead, Quality engineer, or similar role within pharmaceutical industry.
• English B2 language level is required.
• The levels of computer proficiency are intermediate level for MS office, routine level for data analysis, and specialist level for business applications.
• Positive attitude, proactivity, decisive, and organized with an ability to work individually and in a team.
• Stress-resistant, continues to work calmly under all circumstances.
• High degree of accuracy and quality attitude.
• Flexible, can deal with changing priorities.
• Shows accountability by proactively addressing issues and taking responsibility for outcomes.
• Analytical thinking: ability and dealing with complexity, asking questions, using data, using information and identify gaps and root causes of issues and think out of the box to develop a solution.
• Prioritize tasks effectively to meet deadlines and ensure timely delivery.
• Maintains effective alignment with stakeholders and establishes meaningful connections with customers.

This role offers a very competitive hourly rate. This contract will run for 12 months

you are welcome here.

Johnson & Johnson is 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.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process.

Diversity, Equity & Inclusion.

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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each 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”.