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JOB DESCRIPTION:

Are you ready to take on a unique and exciting opportunity as a Data & Trend Specialist in the Medical Device Sector? Johnson & Johnson is seeking a highly motivated individual to join our team in Nijmegen, Netherlands with one year limited 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 Data & Trend Specialist, 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 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.

REQUIREMENTS:

• Quantitative degree (e.g. Statistician, Process Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Metrology, Optical Engineering, Chemical Engineering, Reliability Engineering, Chemistry, Physics, Toxicology, etc.)
• External certification/training that includes statistical techniques (e.g. black belt certification, ASQ (American Society for Quality)) and/or completed internal statistical training.
• 1 year of Data Analytics experience
• Manufacturing experience
• Experience with root cause analysis and implementation of preventative and corrective action
• Experience in a QMS or regulated environment (ISO 13485 / FDA is preferred)
• Demonstrated proficiency in Excel (pivot tables), Minitab (or equivalent)
• Teamwork skills
• Excellent written and verbal communication skills
• Attention to detail
• Excellent mathematical and analytical skills
• Knowledge of statistical software analysis
• Strong time and project management skills

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

• Data analytics (statistical analysis) with focus on manufacturing process data for product and process understanding initiatives; analyze data, including charting and trend analysis and present results to management.
• Product performance trending, report generation & gathering and presenting in a highly structured manner critical data needed for management to decide upon (changes in) specifications.
• Perform analysis of trends of relevant QMS’s processes and measurement of KPI’s and quality goals. Present reports during Management Reviews.
• Act as Statistical Lead Subject Matter Expert (SME) assisting process owners with the design/selection/application of appropriate statistical methods.
• Creation and ownership of statistical technique training.
• Aids with product complaint investigations, and CAPA’s and NCR.
• Assist in ensuring that the Quality System is followed company-wide; assist in the Internal Audit process and External Audits.
• Ensuring animal material is part of risk management strategy in GATT Technologies QMS in compliance with ISO 22442 “Medical Devices Utilizing Animal Tissues and their Derivatives”.
• Lead or assist with establishing validation and /or qualification policies. Lead or assist identification of validation problems for equipment and /or performance processes and develop, review or execute validations documentation (eg. IQ, OQ, PQ and verification studies).
• Support manufacturing scale-up projects and comparability studies.
• Providing Computer System Validation oversight to ensure compliance with regulatory requirements and internal policies and procedures throughout the application life cycle.
• Data analysis, root cause investigations and corrective action implementations; product related customer complaint investigation; responding to internal customers/stakeholders quickly and effectively; prioritizing work efficiently to meet cycle time targets and deadlines (production real time support); Compliance to the sites QMS along with ISO 13485 and 21QSR820.
• Keep and update trend files; ensure compliance with safety and quality standards & collaborate with engineers and technicians on projects.
• 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.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed