Description
- This position will require to be based on-site 3 days a week in Nijmegen.
Change lives for the better.
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 at https://www.jnj.com/.
THE OPPORTUNITY
Are you ready to take on a unique and exciting opportunity as a Quality Engineer in the Medical Device Sector? Johnson & Johnson is seeking a highly motivated individual to join our team in Nijmegen, Netherlands. This is your chance to be part of a world-class organization that is committed to innovation and delivering flawless quality in everything we do.
As the Quality Engineer, you will play a crucial role in ensuring that our operations meet the highest standards of quality and compliance. You will have the opportunity to work with a team of exceptional professionals and contribute to the success of our goals.
This position reports to the direction of Quality Operations Lead.
In this job, you will use quality engineering principles, tools and techniques to develop, and optimize, and support systems and processes that are aligned with the overall Company strategy and mission affecting continuous quality improvement. Utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. Ensure compliance with company policies and procedures such as Design Control, Process Validation, Test Method Validation, and Sampling Plan Development and Review. Generates quality indicators and supports nonconformance investigation and corrective action implementation at the business unit level. Ensure compliance of quality records and QMS associated systems.
Further responsibilities:
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Supports, consults, trains and leads quality improvement projects throughout the life cycle of the product, including product design and development, manufacturing, purchasing, and improvements.
- Utilizes quality engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participate in EMEA activities.
- Conducts investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Demonstrates independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
- Develops, writes and approves as required policies, procedures, test methods, specifications.
- Assesses the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Assesses whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance.
- Assists with establishing validation and/or qualification policies. Assists in identification of validation problems for equipment and/or performance processes and develops, reviews or executes validations documentation (e.g. IQ, OQ, PQ and verification studies).
- Ensures that software validations are performed according to applicable FDA guidelines. Provides end-user support by software validation throughout the Software Validation Life Cycle.
- Supports External and Internal audit. Leads or acts as team member of audit observation investigation and action plans.
- Collects data, executes/conducts various analytical/statistical analysis and interpretation, prepares reports and provides information as part of process improvements and day-to-day support.
- Provides Training/Consultation on quality concepts, quality technology tools, nonconformance and investigations.
- Is responsible for communicating business related issues or opportunities to next management level.
- Is responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Qualifications
IT’S ALL ABOUT YOU
To be successful, you demonstrate the ability to communicate effectively at all levels within a virtual matrix environment. Further requirements include:
- Bachelor’s degree (B.S.) in engineering, science, mathematics or statistics is required.
- A minimum of two years related manufacturing experience and/or training; or equivalent combination of education and experience is desired.
- Demonstrated knowledge of good manufacturing principles and practices, and procedures.
- Knowledge of ISO13485 and cGMP regulations is required.
- An ASQ certification (CQE, CQM, CRE or CQA), Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred.
- Ability to work on cross-functional teams and to communicate effectively within diverse interdepartmental groups is required.
- Technical training and experience using Statistics, Lean and/or Six Sigma Methodologies is preferred.
- The ability to perform "hands on" troubleshooting and problem solving is required. Good technical understanding of manufacturing equipment and processes is required.
- Ability to periodically interact with associates and processes in a special environment such as a Controlled Manufacturing Environment is required. This position will involve periodic entry into Controlled Manufacturing Environment production environment which requires certain preparation and gowning practices.
Closing date: Monday, 16th of December 2024.
Being part of Johnson & Johnson can change everything, including YOU
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 and every 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”!