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Quality Engineer (f/m)

 
 
 

C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manu­facturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty pro­ducts, employing over 16,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.

We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.

Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.

We are looking for the competent support of a highly motivated

Quality Engineer (f/m)

Responsibilities:

  • Works with cross-functional product development and sustaining teams to develop, transfer, launch, and maintain high quality, innovative and compliant medical devices
  • Ensures compliance with design controls and validation requirements, leads and supports product testing and risk management, generates and updates procedures, and serves as a key resource for associated ISO, EN, MDR and QSR requirements
  • Generates, approves and oversees verification, validation and aging studies in collaboration with product development/R&D engineering
  • Generates, updates, maintains, and approves FMEA/risk analysis/risk management documentation
  • Performs statistical analysis to determine process capability, design acceptance and to analyze trends
  • Maintains design history files
  • Supports the corrective/preventive action (CAPA) program by conducting root cause analysis and applying problem-solving techniques and by implementing corrective/preventive actions

Qualifications/Skills:

  • Bachelor's degree or higher graduate degree in a science/engineering-related field
  • Effective oral and written communication skills
  • Good English language skills (written and spoken fluency)
  • Good computer skills and the ability to learn appropriate software
  • Process- and detail-oriented working style
  • Ability to work in a team
  • Working knowledge of appropriate global medical devices regulations and standards, such as ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC) is a plus
  • Basic knowledge of comparative statistics
  • Ability to create, review and coordinate test protocols and reports

If you would like to apply for this position, please send a complete application (comprehensive CV, copies of reference letters, availability) to the attention of Mr. Andreas Arndt, Senior Human Resources Manager, by e-mail to: HR.Germany@crbard.com.

For further information please visit our website at www.crbard.com

angiomed GmbH & Co. Medizintechnik KG · Wachhausstraße 6 · 76227 Karlsruhe