Quality Manager (m/f/d)

Facts

  • Office: Heidelberg
  • Schedule: full time

Job-ID

MC2112_001

We are looking for

We are looking for a Quality Manager (m/f/d) to join our team on a full-time basis.

Your responsibilities

  • Further development, maintenance and upkeep of the quality management system in accordance with the applicable requirements, e.g. ISO 13485, ISO 9001 and taking into account the standards IEC 62304, ISO 14971, IEC 62366
  • Preparation, implementation and monitoring as well as follow-up of 1st party, 2nd and 3rd party audits
  • Analysis of processes, further development and creation of procedures
  • Contact person for external partners such as authorities and notified bodies
  • Operational preparation, provision and distribution of approval documents for worldwide approval
  • Standards and specification management
  • Participation in risk management
  • Maintenance and expansion of the company's own documentation systems
  • Preparation and processing of reports/evaluations
  • Support in the validation of software products
  • Support in the creation and maintenance of technical documentation
  • Know and understand relevant national and international regulations (laws, ordinances, guidelines, standards) and be able to assess the conformity of documentation with these regulations.
  • Know and understand the manufacturer's products (medical context, physical principle, technical design)

Your qualifications

  • Successfully completed scientific training or a comparable qualification
  • Experience in the medical device environment
  • Knowledge of GAMP as well as project, quality and document management
  • Confident handling of MS Office, Share Point and workflow systems
  • Knowledge of relevant regulatory requirements, especially GAMP, DIN EN ISO 13485, Quality System Regulations (FDA)
  • Experience in project management
  • Very good knowledge of German and English, both written and spoken

Your profile

  • Didactic skills to communicate regulatory requirements
  • Strong communication and assertiveness skills
  • Precise, structured and pragmatic way of working
  • Ability to work in a team and high level of initiative

We offer

  • Interesting and challenging tasks in an international, dynamic company 
  • Open corporate culture and very good working atmosphere 
  • Possibility of mobile working
  • Modern equipped workplaces 
  • Performance-related remuneration
  • A highly motivated team in an international environment 
  • Attractive location in Heidelberg in the Bahnstadt incl. job ticket
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