Staff RAQA Specialist in Venlo at Stryker Corporation

Date Posted: 9/28/2020

Job Snapshot

Job Description

The Job's Mission   

The Staff RAQA Specialist is owner of multiple QMS processes and acts independently as a liaison for the CDC in regarding Quality Management System, Value Added Services and Continuous Improvements. The Staff RAQA Specialist defines and develops Labeling and Kitting process requirements to make sure the CDC organization keeps meeting the Legal, Corporate, ISO 13485 and FDA RAQA requirements. This role ensures a standardized and structured approach to Stryker, CDC and RAQA processes which will also make sure that all external and internal Stakeholders are aware and acting according to their roles and responsibilities. 

Key Activities & Accountabilities   
Within the 4 key pillars of our organization the Senior RAQA specialist is responsible for: 
Secure business continuity and day to day :

  • QMS Process Ownership, KPI management and  including where applicable Document and Record Control.
  • CAPA process handling, tracking progress and status
  • Input owner to support the Organization regarding Quality Policy, QMS, Regulatory and Quality in general  
  • Independently working in teams regarding Process and Organization Change Management
  • Act as the RAQA manager delegate in daily processes and projects
  • Any other RAQA activities as defined by the RAQA Manager 

Strengthening the base:

  • Supporting and developing the ELPO VAS strategy on labeling and Kitting
  • QMS processes reporting to stakeholders in and outside CDC.
  • Act where needed as RAQA Manager back-up towards the local teams 

New Business Needs/ Opportunities:

  • Supporting M&A, projects and Business integrations to enable growth.
  • Preparing and Acquiring correct Management and RAQA approvals where needed  

Develop for the future:

  • Network and work with global Stryker stakeholders to review Strategy and CDC QMS and processes 

Profile & Competences

  • Vocational Education (HBO+).
  • A minimum of 5 years’ experience in RAQA role
  • Education in or knowledge of logistics processes and/or RAQA processes  
  • Proven experience of working in the Medical Devices industry specifically regarding value added services activities
  • A minimum of 5 years working in an ISO13485, FDA medical devices or Quality function related environment.
  • Customer and Service minded, Hands-on, Proactive.
  • Excellent communication and interpersonal skills resulting in Business improvement and increased results
  • Team player and able to positively influence others  

Work From Home: Not available

Travel Percentage: 10%

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