Complaint and Medical Device Vigilance Specialist (m/f/d)

Return to Search
Apply Now
Schönkirchen, SH, 24232, DE
Job details
Work flexiblity: Hybrid or Onsite Req ID: R533413 Employee type: Full Time Job category: RAQA Travel: 10% Relocation: No

Related content

Why join Stryker?

Looking for a place that values your unique talents? Discover Stryker's award-winning culture.

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

Job description

As a Complaint and Medical Device Vigilance Specialist (m/f/d) at Stryker, you'll play a critical role in ensuring patient safety and compliance by managing and investigating product complaints related to our innovative medical devices. Join us and become part of a team dedicated to delivering solutions that improve lives worldwide.

What you will do:

  • Investigate medical complaints to identify root causes and implement corrective actions (NC/CAPA).

  • Perform or coordinate device inspections and analyze production records, risk management files, and instructions (Operative Techniques/IFU/Reprocessing).

  • Document and manage complaint data and test results in global systems (CHS, TrackWise, Windchill OnePLM).

  • Conduct statistical analyses to identify trends and drive quality improvements.

  • Collaborate with cross-functional teams, including R&D, regulatory affairs, medical affairs and manufacturing, to address product safety and quality issues.

  • Provide necessary information to regulatory compliance teams and support early product surveillance investigations.

What you will need:

Required:

  • Bachelor’s or Master’s degree in Science, Engineering, or a related field, or equivalent technical qualifications.

  • 0-2 years of experience in quality management, complaint investigation, root cause analysis, or a related role.

  • Excellent English and communicative German language skills, enabling seamless collaboration with global and local stakeholders.

  • Good analytical and organizational skills. Strong team player. 

Preferred:

  • Previous experience in the medical device or manufacturing industry.

  • Basic understanding of medical device regulations (e.g., ISO 13485, FDA standards) and quality processes, including NC/CAPA and complaint handling systems like TrackWise or MasterControl.

Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity. 

Additional information  

Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of 1 day on site at our location in Kiel should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.

Please note that the internal job title may differ from the ad title. 

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Apply Now