Quality Engineer

Quality Engineer 

Location: Leiden, Einsteinweg

Duration: 12 months

Hours: 39 hours per week

Imagine your next project as a Quality Engineer, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

roles and responsibilities

Experienced support individual contributor that executes tasks that are both routine

and not routine. Organizes Quality activities associated with team deliverables.

Assembles and leads the team required for quality records. Escalates issues and

risks as required. Demonstrates effective communication skills with both internal and external customers. Maintains high standards of professionalism, efficiency, personal communication, discretion, and independent judgment.

This will involve: 

• Demonstrates Johnson & Johnson’s Leadership Imperatives and Credo in day-to-day interactions with team.

• Is required to understand and comply with the Code of Business Conduct, Company policies and laws that govern their activities.

• Perform related duties as assigned by supervisor.

• Applies expertise knowledge of Quality requirements to support the execution of Operations unit objectives

• Perform nonconformance 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.

• Takes ownership of personal training and ensures that all required training is understood and completed on time.

• Enhance a culture of belonging through trusting, divers, & inclusive relationships.

• Additional tasks and job duties of the position that are not required daily:

• Supports the Subject Matter Expect on non-conformances and Change Controls during inspection and audits.

• Support developing training programs for general cGMP processes.

• Formulate responses to observations from audits and inspections.

• Conducts data analysis on recurring non-conformances and recommends corrective actions.

how to succeed

You will be an excellent communicator, have the ability to both find possible issues but also find solutions. You will be proactive, have the initiative to solve problems and voice your opinions. You will also bring: 

Essential:

• A relevant HBO degree with 3 years relevant experience within Quality.

• Experience within a similar environment ie. GxP, GMP, Medtech or Lab environment 

• Experience using a Quality Management System (QMS)

• English B2 language level is required. (Dutch is a nice bonus)

Other:

• 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.

• Previous experience with leading or providing significant guidance of change controls or quality investigations.

• Practices giving and receiving transparent and constructive feedback, learn from mistakes, and drive initiatives to achieve organizational and personal development goals.

• Coordinates team initiatives by providing clear direction and ensuring effective collaboration within the team.

details

This contract will run for a 12 month duration. This is a hybrid position (3 days on site, 2 days at home). 

you are welcome here

 Johnson & Johnson Innovative Medicine 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 Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

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. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

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”.