Senior Specialist, Change Control in Carrigtohill at Stryker Corporation

Date Posted: 11/6/2018

Job Snapshot

Job Description

Will work within the QMS team, under general supervision ensures compliance to Change Control processes and procedures and is responsible for, but not limited to.

  • Lead & execute the change control board review forums. Participate in multi-site and global forums.
  • Liaise with relevant functional groups, facilitate and mentor teams through all stages of the change control process. Supports and coaches the change owners and initiators.
  • Acting as change analyst & approver, have responsibility for review and approval changes to processes and procedures, with attention to detail, review for completeness, accuracy, effectivity and appropriateness
  • Reviews for sound rationale, challenging justification, correct approval and oversight and resulting status of change requests. 
  • Ensuring users provide the necessary rigor to the PLM system content including maintaining a live document with all relevant evidence attached, in a timely manner.
  • Subject Matter Expert on all related procedures and process SME, ensuring compliance to the relevant corporate procedures. Super user of PLM system.          
  • Ensure adequate training is developed, maintained and provided to all users of change control process & systems.                                                               
  • Manage & monitor site Change Control  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
  • Interface between divisions & GQO sites, and functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes.
  • Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
  • Lead &/or participate in cross-plant and corporate project teams in areas of change management and quality systems improvement.
  • Lead/coordinate preparation, participate and follow up to Stryker Internal, Corporate and third party compliance audits.

Work From Home: No

Travel Percentage: None

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