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JOB DESCRIPTION:

Are you ready to take on a unique and exciting opportunity as a Senior Quality Engineer in the Medical Device Sector? Johnson & Johnson is seeking a highly motivated individual to join our team in Nijmegen, Netherlands with a 1 year fixed-term contract. 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 Senior 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.

REQUIREMENTS:

• Bachelor’s degree (B.S.) in engineering, science, mathematics or statistics is required.
• A minimum of five years related manufacturing experience in medical device industry.
• 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 with cross-functional teams and to communicate effectively within diverse interdepartmental groups is required.
• Ability to work on own initiative and as a team player.
• Technical training and experience using Statistics, Lean and/or Six Sigma Methodologies is preferred.
• Ability to prioritize multiple commitments and technical problem-solving duties.
• 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.

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Support, consult, train and lead quality improvement projects throughout the life cycle of the product, including product design and development, manufacturing, purchasing, and improvements.
• Utilize quality engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities.
• Lead investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Demonstrate 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).
• Responsible for review and approval of qualification / system related procedures/work instruction.
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Assess 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.
• Assist with establishing validation and /or qualification policies. Assist in identification of validation problems for equipment and /or performance processes and develop, review or execute validations documentation (eg. 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.
• Support External and Internal audit. Lead audit observation investigation and action plans.
• Collect data, execute/conduct various analytical/statistical analysis and interpretation, prepare reports and provide information as part of process improvements and day-to-day support.
• Provide Training/Consultation on quality concepts, quality technology tools, nonconformance and investigations.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.