Quality Systems Manager (m/f/d)

Occupation: Quality Systems Manager (m/f/d)

SternMed GmbH is a growing medical technology company based in southern Germany. We are committed to manufacturing and distributing a wide range of affordable German quality medical equipment globally while offering long-term commitment and local local support. We are a supplier of diagnostic imaging equipment (X-Ray, ultrasound, MRI, CT), OR solutions (operating tables and lights, anesthesia machines, RF surgery devices) and patient care (patient monitors, ventilators, medical pumps).

We are looking for a dedicated Quality Systems Manager (m/f/d) with immediate effect.

Your tasks

  • Application of the MDR (Medical Device Regulation) and medical device regulations
  • Preparation of technical documentation in accordance with the requirements of MDR 2017/745, in particular for market surveillance and market analysis (PMS, PMCF, PSUR)
  • Co-design and development of our quality management system
  • Registration of our products outside the EU
  • Carrying out supplier audits
  • Support for internal and external audits

Your profile

  • Training or studies with experience in the mentioned field or comparable, career changers are welcome
  • Ideally, professional experience or regulatory training in the field of medical devices or regulatory affairs
  • Ideally, knowledge of the legal and normative requirements for the medical device industry is an advantage for the EU and other countries
  • Experience in the field of quality management systems for medical devices
  • Very good knowledge of German and English, both written and spoken
  • Organizational skills
  • Diligence, reliability and ability to concentrate
  • Ability to work independently
  • Confident handling of MS Office applications (eQMS, Dynamics Nav, Risk Manager is an advantage)

We offer 

SternMed GmbH offers you a positive and familiar working atmosphere as well as the opportunity to contribute your skills to our passionate, multicultural team. A pleasant working environment at a high technical level, characterized by the diversity of our employees, their skills and approaches. We stand for an open and appreciative corporate culture with flat hierarchies and personal responsibility.

 

Type of job:

  • Full-time (40 hours)
  • Permanent position
  • no shift work
  • 30 days of vacation

Benefits:

  • attractive salary
  • company pension scheme
  • in-company training opportunities
  • free drinks (water, coffee, tea)
  • free parking

Homeoffice:

  • No

Candidates applying for this position should meet all legal requirements to work in Germany. Visa sponsorship is not available at this time. Thank you for your understanding.

Have we piqued your interest?

Then we look forward to receiving your detailed application with details of your starting date and salary expectations!

Please send your application via the link below or to the following email address:

Julia-Maria Enderle
hr@sternmed.de

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