Quality Assurance Engineer

Hybrid
Mid-level
🇳🇱 Netherlands
QA Engineer
Quality assurance

Work Flexibility: Hybrid

In your new role as the Quality Assurance Engineer, you will be part of the Central Distribution Center (CDC) QA Team with a mandate to support CDC day-to-day activities including NC/CAPA, Commercial Hold, MRB, Value Added Services, Product Complaint processes, implement quality standards, ensure, and execute compliance on every stage of the process. You will assess potential risks, gives recommendations, works closely with CDC operational partners on quality related topics, process improvements and lean initiatives. You will take responsibility for all quality control aspects of the process.

Opportunities & benefits that the role offers

  • This person will get great exposure to all Stryker Divisions.
  • Opportunity to work on fulfilling projects with colleagues within the department and cross-functionally.
  • Help shape the future of the GLO Quality team to ensure quality products & best-in-class service is provided to internal and external customers.
  • Work in the Netherlands’ 5th best “Great (Large) Place to Work”.
  • Attractive flexibility in working arrangements.

Is this you?

You have Experience You have at least 2 years’ experience in a Quality Assurance Engineering or similar role, and you have experience of working in an ISO13485, FDA QSR or other regulated Quality function environment. You have previous experience in continuous improvement and/or application of lean tools & concepts. Experience in Logistics, Warehousing, and Distribution would be a preference.

You speak Fluent English A key part of this role will be to work with international stakeholders across the world. Knowing one or more additional languages is a plus.

You love a Challenge A self-starter who enjoys problem solving and creating innovative solutions. You can organize and direct diverse activities in a changing environment, often under time pressure.

You Know what you are Doing You have experience in Problem Solving/Root Cause Analysis (including NC/CAPA Investigation). You will have Knowledge & Application of Quality Assurance (including GDP and Risk Based Approach). You have administrative and analytical skills and are tech-savvy. Experience with ERPs (SAP, Oracle), Trackwise, PowerBI would be a preference.

You Build Relationships You are a team player that works closely with your team members to achieve shared goals. Next to that, you build and maintains successful relationships with key internal and external stakeholders and customers.

You do the Right Thing You have a high level of integrity, responsibility, discipline, and attention to detail. You understand the importance of keeping tabs of what is always going on in your goals/projects.

You are a Strategic Thinker You enjoy analyzing data or trends from multiple sources and formats and create a comprehensive scientific review, including in depth statistical analyses, risk management cross-check and descriptive analyses.

What will you do at Stryker?

  • Process Task Ownership including where applicable tasks regarding Training, Document and Record Control.
  • NC/CAPA support and where applicable NC/CAPA ownership.
  • Supporting Change and Risk management processes.
  • Process reporting to stakeholders in and outside CDC.
  • Driving improvements regarding Labeling, Process and Quality Management System to ensure compliance with applicable standards and regulations
  • Assisting on internal and external auditing.
  • Collaborating with internal CDC Stakeholders and Stryker Design Divisions regarding product disposition and other queries.
  • Non-conforming product handling, participating in Material Review Boards where applicable/
  • Product Complaint reporting to the manufacturing sites, tracking progress and status
  • Execution of Commercial Hold.
  • Supporting the CDC group with implementation and maintenance of Value-Added Service initiatives including labeling, kitting, and other as applicable.
  • Collaborating with internal & external stakeholders regarding process improvements and lean initiates.
  • Any other QA activities as defined by the QA Manager. Travel Percentage: 0%

 

Stryker Employment Company, LLC

Stryker Employment Company, LLC

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