Senior Staff Quality Engineer in Venlo at Stryker Corporation

Date Posted: 11/2/2018

Job Snapshot

Job Description

The Job's Mission 

The Staff Engineer owns validation, maintenance and calibration processes, and supports on the implementation project for MDR. The Staff Engineer CDC will be the specialist and offers QMS advice, information and support to management, supervisors and employees in terms of Value Added Services changes or additions, also in such a way that the organization keeps meeting all Legal, Corporate, ISO 13485, FDA RAQA and other requirements. This role ensures a standardized and structured approach to Postponement QMS integration which will also make sure that all external and internal Stakeholders are aware and acting according to their roles and responsibilities.

Key Activities & Accountabilities  

The Staff Engineer CDC is responsible for:
 

  • Validation process ownership and site validation compliance according Stryker and ISO/QSR standards.
  • QMS Process controls out of Risk Assessment
  • NC/CAPA finding ownership and support roles (NC, Root Cause Analyses, CAPA assessor)
  • Owning QMS Postponement integration including assuring correct and timely closure of projects;
  • QMS Projects and status reporting to stakeholders;
  • KPI’s, KPI target results and Continuous Improvement for the owned processes;
  • Any other RAQA activities as defined by the RAQA Manager.


Profile

  • Solid understanding of and experience in logistics and project planning;
  • Solid understanding and 2-3 years working experience with SAP ERP;
  • Solid understanding of European Medical device Regulation;
  • A minimum of 7 - 10 years’ experience in similar Quality role;
  • Experience of working in the Medical Devices or other regulated Industry.
  • Experience of working in an ISO13485 and/or FDA medical devices related compliant environment;
  • Experience on MD Risk assessment (preferably FMEA) and QMS integration;
  • Customer and Service minded, Hands-on, Proactive;
  • Structured, tidy and precise;
  • Team player.




Competencies
 


  • Bachelor degree required, preferable in Industrial Engineering or equivalent study;
  • Knowledge of logistics processes, RAQA and preferably Kitting, Labeling or other MD manufacturing activities;
  • Ability to prepare plans, monitor, report status, drive team performance regarding delivery and budgets;
  • Knowledge of ISO 13485 and FDA Medical regulations;
  • Knowledge of Risk assessments, Root Cause Analyses, complaints handling;
  • Excellent knowledge of the English language; German would be a plus;
  • MS Office advanced experience;
  • ERP software experience; Experience with Oracle would be a plus;
  • Excellent communication and interpersonal skills.
  • Experience with International Standards (e.g. MDD/MDR/FDA etc.)






Reporting / Communication lines

  • Reports to CDC RAQA Manager;
  • Stryker CDC communication: CDC Operations, CDC RAQA, Employees;
  • External communication: Stryker VAS Stakeholders and RAQA sources.

Work From Home: Yes

Travel Percentage: Up to 25%

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