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Quality & Regulatory Affairs Specialist - Capital Equipment (m/w/d)

Remote: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

Proven experience in capital equipment servicing, Knowledge of ISO 13485 standards, Fluency in German and English, Advanced IT skills including Excel and SAP.

Key responsabilities:

  • Establish and improve service processes
  • Ensure accuracy of administrative processes
  • Coordinate maintenance, repairs, and installations
  • Participate in projects and validation activities
  • Advise management and collaborate across departments
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Zimmer Biomet XLarge https://www.zimmerbiomet.com/
16697 - 16697 Employees
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Job description

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Your missions

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.


As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.


What You Can Expect


As a Quality & Regulatory Affairs Specialist (m/w/d), you will be in charge of providing support to Capital Equipment servicing as well as to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance.


How You Create Impact


  • Establish, implement and improve service processes, procedures and best practices
  • Ensure efficiency and accuracy of service department's administrative processes
  • Coordinate and administrate scheduled maintenance activities, emergency repairs and equipment installations
  • Participate in special projects and special duties like (re-)validation of technical systems and procedures
  • Play a key role in growing revenue and margin from spare parts and service contracts
  • Participate and join strategic initiatives for the service department that align with overall business objectives
  • Advise general management and work close together with other departments to support the business


What Makes You Stand Out


You have a proven track record in working within Capacital Equipment servicing, ideally in Medical Devices or Pharmaceutical industry.

You have developped the ability to work both independently as well as in a matrix organisation and to collaborate with stakeholders across all organisation.


What Will Make You Successful


  • Knowledge of ISO 13485 and the Medical Device Regulation desirable
  • Ability to prepare high quality, clear communication materials to the appropriate audience
  • Advanced IT skills – Excel, PowerPoint, Windchill, SAP
  • Fluency in German and in English
  • Discretion and confidentiality


Who We Are


Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.


Looking to make an impact? Join us and make a difference.

Learn more about us by visiting zimmerbiomet.com

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
Check out the description to know which languages are mandatory.

Hard Skills

Soft Skills

  • collaboration
  • verbal-communication-skills
  • quality-assurance
  • technical-acumen
  • microsoft-excel
  • microsoft-powerpoint

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