Johnson & Johnson Loopbaan
Quality Specialist NC/CAPA
Requisition ID: 1905712166W
- Maintains quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner.
- Makes proposals and assists in the development of corrective action plans and monitors implementation.
- Lead CAPAs, NCs and Audit Observations
- Follows up on closure of corrective and preventive actions
- Assures that non-conformance investigations and quality systems are in compliance with the good manufacturing practices as established in the code of local government regulations and company procedures
- Develop and implement reports for quality data for ELC/JJI and other plants if required
- Lead on-going efforts to improve ELC Quality System where applicable.
- Work effectively with the other ELC departments and corporate liaisons to ensure consistent/effective quality systems.
- Support site lead for (WW) Quality system related improvement projects.
- Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes
- Has thorough understanding of process criteria and regulations and business impact of decisions and actions
- Assesses current quality systems and recommends improvements in order to enhance quality
- Prepares for and facilitates audits and inspections
- Monitors trends, identifies issues, recommends and implements appropriate actions
- Develop and implement appropriate Quality Procedures
- Refers extraordinary situations to the quality assurance manager for final approval.
- Ensure effective change control.
- Supports the site in identifying and eliminating compliance risks.
- Ability to work under own initiative with minimum supervision
- Participate in project teams in JJI/QOPS relating to Quality.
- Ensure active and thorough investigation of quality issues and effective corrective and/or preventive action.
- Ensure compliance with company policies and procedures.
- Provide guidance and recommendations involving the implementation of regulatory requirements (e.g. Quality System Regulation, EU MDD, ISO standards, etc.)
- Reports any nonconformance's to the quality assurance manager.
- Partner with European manufacturing plants and key business partners.
- Partner with distribution centers and affiliates in the investigation/correction of process failures.
- Proactively communicate any changes in design or changes in process that could affect product.
- Ensure distribution centre and affiliate performance is monitored and addressed as needed.
- Provide leading metrics to Quality Assurance Manager.
Education and/or Experience
- Appropriate Engineering, Life Science, Physical Science or Business Degree.
- PE Green Belt or Black Belt certified preferred.
- Related experience to demonstrate skills required.
Other Skills and Abilities
- Demonstrated knowledge and application of QSR, MDD, ISO9001, 9002, 13485, 14971 and other international standards.
- Working knowledge of Good Distribution Practice.
- Fluency in English
- Practical experience of Lean Manufacturing and Lean tools.
- Computer Skills (Word, Excel, PowerPoint, Minitab, Visio, Project).
- Effective communication skills.
- Effective technical writing.
- Sense of urgency, intellectual curiosity, prudent risk-taking.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
European Logistics Center (8785)