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Quality CAPA Manager - Ireland / Dublin - Stryker Corporation

Date de publication : 5/23/2019

Résumé de l'offre

Description de l'offre

As leader of the quality systems team has responsibility for delivering the compliance and business objectives for the NC/CAPA Function ​iled job description here.

Working within the QMS team, under minimal supervision, ensure compliance to CAPA processes and procedures and is responsible to, but not limited to.

  • Have responsibility for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity and timeliness. Review & Approval of CAPA changes including extension requests.                                                                                                           
  • Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC / CAPA process.
  • Contribute in developing optimum future state of the NC / CAPA process for business needs, aligned with Corporate
  • Develop & deliver training and coaching for new CAPA users on CAPA principles and on the system
  • Coordinate between potential different organizations which have to interface
  • Ensuring users provide the necessary rigor to the eCAPA system content including maintaining a live document with all relevant evidence attached, in a timely manner.
  • As Problem Solving Methodology expert,  facilitate and coach NC & CAPA teams in the application of problem solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc.
  • Subject Matter Expert on all related procedures, ensuring compliance to the relevant Corporate procedures. Super user of eCAPA system.                                                                 
  • Lead & execute the NC/CAPA Review board forums. Chair and lead Global/ multi-site forums.                                        
  • Manage & monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums, also liaising with other GQO sites to ensure compliance to global requirements & metrics are achieved.
  • Ensure adequate training is developed, maintained and provided to all users of CAPA process & systems.                                                                                                            
  • Identify and lead continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
  • Provides review and input into global procedures.
  • Identify opportunity for improvement, lead &/or participate in cross-plant and corporate project teams in areas of CAPA and quality systems improvement.
  • Lead/coordinate preparation, participate and follow up to Stryker Internal, Corporate and third party compliance audits.

Work From Home: Yes

Travel Percentage: Up to 50%

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