Quality Engineer - Investigation Owner

Johnson & Johnson; Leiden; On-site; EUR 55,000 - 83,000; Full time

Job summary

Johnson & Johnson is seeking a Quality Engineer (Investigation Owner) to lead and manage investigations related to manufacturing processes and products. You will identify root causes, coordinate CAPA actions, and ensure regulatory compliance while collaborating with cross-functional teams.

The role requires a HBO degree with 3–5 years of pharma experience, English B2, and strong data analysis and documentation skills. The contract is 12 months and the environment is highly professional.

Qualifications

• HBO degree with 3–5 years in quality investigations or similar roles in pharma.
• English level B2 required and strong problem solving skills.
• Experience leading quality records, CAPA and change controls.

Responsibilities

• Lead and manage quality investigations across manufacturing processes and systems.
• Coordinate CAPA records and change controls from initiation to completion.
• Review process documentation and ensure GMP compliance on the production floor.
• Escalate risks and drive continuous quality improvements with stakeholders.
• Perform GEMBA walks to observe and document adherence to GMP standards.

Skills

Quality investigations

CAPA handling

Root cause analysis

GEMBA walks

Documentation

Education

HBO degree in quality/engineering

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.

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”.