Quality Specialist NC/CAPA
Locations: Diegem, Belgium
Functions: Quality Assurance
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Requisition ID: 1905712166W
Job Title: Quality Specialist NC/CAPA
Division: JJ International/ELC and Ethicon Quality Operations
Supervisor Title: QA manger
The Quality Specialist, NC/CAPA performs quality support duties including maintenance of the corrective action and preventive action (CAPA) and supplier systems as well as providing support for special quality projects. He/ she ensures and maintains a state of inspection readiness and performs in various quality functional areas and maintain expertise. Furthermore he/ she will act as the CAPA and NC Site Lead.. Partnering with European manufacturing plants and key business partners:
* 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
Principal Duties and Responsibilities (essential functions) (current duties and/or responsibilities which account for more than 50% of job)
* 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.