Helps. Cares. Protects.

Join our team as a

Senior Manager (f/m/d) Validation Engineering 

DEU-Heidenheim

 

As part of the Process Assurance Team, we offer you an exciting and responsible task in a globally operating functional area. We enable our employees to get involved in interesting tasks in a modern working environment and to grow with them, as well as to develop professionally. If you are also enthusiastic about our meaningful product portfolio, we should get to know each other.
 

Your area of responsibility:     
 

  • Planning, management, and implementation of computer system validations for digital solutions and internal applications
  • Conducting process audits and providing technical support for supplier audits
  • Preparation, review, and approval of validation documents for computerized systems and digital applications
  • Advising the business units on the development of digital solutions in the health sector, as well as digital medical products
  • Contributing to the continuous improvement of internal processes and specifications for computer system validation
  • Support in auditing suppliers of computer systems

 

What we look for:
 

  • Completed technical studies towards a Bachelor's or/and Master's degree in engineering or another technical discipline
  • Professional experience from the medical devices environment in the area of quality, especially DIN EN ISO 13485, 21CFR Part 820 and Part 11, EU Annex 11, GAMP and ISO 62304
  • Experience in validation and development of electronic products, software and systems
  • Proven experience in the management and implementation of projects as well as a high level of competence in solving technical tasks
  • Very good communication skills, ability to work under pressure and strong analytical skills 
  • Team player, intercultural competence, and excellent stakeholder management 
  • Ideally experience in conducting audits and project management experience
  • Profound SAP user skills and MS Office knowledge
  • Business fluent German skills C2, english B2 an advantage

 

Benefits

 

  • Stable and continuously growing company with over 200 years of history
  • Flexible working conditions, e.g. flexitime or mobile working on a daily basis
  • Attractive ways of combining work and family life, e.g. parent-child workroom
  • Subsidized company vehicle in a full-service leasing model incl. private usage
  • Company pension plan with attractive employer contribution incl. matching model for deferred compensation
  • Various employee offers e.g. Corporate Benefits platform and various health and fitness offers, e.g. yoga during lunch break, cooperation with fitness studios, company doctor, massage offers
  • Well-developed infrastructure e.g. canteen, parking bays, well-equipped workspaces
  • Feedback conversations and resulting training opportunities as well as diverse development opportunities

 

 

Please send in your application documents via our online platform to Adele Frommholz.

Helps. Cares. Protects.

Join our team as a

Senior Manager (f/m/d) Validation Engineering 

DEU-Heidenheim

 

As part of the Process Assurance Team, we offer you an exciting and responsible task in a globally operating functional area. We enable our employees to get involved in interesting tasks in a modern working environment and to grow with them, as well as to develop professionally. If you are also enthusiastic about our meaningful product portfolio, we should get to know each other.
 

Your area of responsibility:     
 

  • Planning, management, and implementation of computer system validations for digital solutions and internal applications
  • Conducting process audits and providing technical support for supplier audits
  • Preparation, review, and approval of validation documents for computerized systems and digital applications
  • Advising the business units on the development of digital solutions in the health sector, as well as digital medical products
  • Contributing to the continuous improvement of internal processes and specifications for computer system validation
  • Support in auditing suppliers of computer systems

 

What we look for:
 

  • Completed technical studies towards a Bachelor's or/and Master's degree in engineering or another technical discipline
  • Professional experience from the medical devices environment in the area of quality, especially DIN EN ISO 13485, 21CFR Part 820 and Part 11, EU Annex 11, GAMP and ISO 62304
  • Experience in validation and development of electronic products, software and systems
  • Proven experience in the management and implementation of projects as well as a high level of competence in solving technical tasks
  • Very good communication skills, ability to work under pressure and strong analytical skills 
  • Team player, intercultural competence, and excellent stakeholder management 
  • Ideally experience in conducting audits and project management experience
  • Profound SAP user skills and MS Office knowledge
  • Business fluent German skills C2, english B2 an advantage

 

Benefits

 

  • Stable and continuously growing company with over 200 years of history
  • Flexible working conditions, e.g. flexitime or mobile working on a daily basis
  • Attractive ways of combining work and family life, e.g. parent-child workroom
  • Subsidized company vehicle in a full-service leasing model incl. private usage
  • Company pension plan with attractive employer contribution incl. matching model for deferred compensation
  • Various employee offers e.g. Corporate Benefits platform and various health and fitness offers, e.g. yoga during lunch break, cooperation with fitness studios, company doctor, massage offers
  • Well-developed infrastructure e.g. canteen, parking bays, well-equipped workspaces
  • Feedback conversations and resulting training opportunities as well as diverse development opportunities

 

 

Please send in your application documents via our online platform to Adele Frommholz.