Quality Engineer

Location: Leiden

Duration: 12 months contract role 

Hours: Full-time - Hybrid working 

Essential: Previous experience within a pharmaceutical or medical device organisation & non-conformances and CAPAs

Imagine your next project leading quality assurance initiatives for a global engineering organization, driving continuous improvement, and making a tangible impact on product reliability within an iconic global healthcare company.

The department:

The Quality Engineer is an experienced professional responsible for leading quality assurance initiatives within the Global Engineering Technology – Project Execution (GET-PEx) organization. 

The role:

This role ensures that processes and systems consistently meet or surpass customer expectations, regulatory standards, and industry benchmarks. 

The Quality Engineer plays a vital role in driving continuous improvement, managing complex quality challenges, and mentoring team members on quality topics. As a technical expert and quality leader, the focus is on enhancing product reliability, reducing defects, and optimizing processes to achieve operational excellence.

roles and responsibilities 

Lead quality assurance initiatives, analyze and resolve quality issues, and act as a primary audit contact. This will involve:

• Collaborate with cross-functional teams (Operations, QC, QA) to analyze and resolve quality issues. Communicate and escalate concerns promptly to management. 

• Lead investigations into non-conformances and CAPAs, including risk assessments, root cause analysis, and the successful implementation of corrective and preventive actions.

• Support GMP training compliance by maintaining the GET-PEx curriculum matrix, preparing updates, and assisting management in content review and periodic assessments.

• Serve as the primary contact for internal and external audits/inspections, coordinating support from the GET-PEx department.

• Develop and maintain weekly and monthly quality metrics related to GMP training, document reviews, non-conformance, and CAPA tracking. Investigate and remediate identified issues. 

• Act as the record coordinator for the GET-PEx department, advising on record management, including archiving physical records and ensuring data integrity. 

• Promote quality awareness within the department by sharing relevant topics to reduce recurring issues. 

• Work independently with minimal supervision to meet tight deadlines while ensuring compliance with all company policies and procedures.

how to succeed 

• At least 4 years of proven experience in the (bio)pharmaceutical industry and related academic background. 

• Minimum of 2 years supporting quality functions, including NC/CAPA management, GMP training, and document/record management. 

• Excellent verbal and written communication skills in English, capable of engaging effectively with internal and external stakeholders up to the departmental management level. 

• Experience with risk management tools (e.g., FMEA, HACCP) and root cause analysis techniques (e.g., 5-Whys, Kepler-Tregoe, Ishikawa). 

• Ability to present and defend departmental quality assurance practices and findings to senior management (e.g., SLT, ECB, CCB). 

• Strong analytical thinking skills, with the ability to handle complexity, ask insightful questions, utilize data effectively, identify gaps, and develop creative solutions. 

• Proficiency in computer applications such as MS Office, Tableau, and eDMS.

benefits 

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 We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.

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”.