For the earliest possible start date we are searching for a highly qualified

Senior Consultant Quality Management (m/f) 

to join our expanding QM  team in our Munich , Germany (DE) office.

 

Responsibilities:

  • Provide interpretation of law and regulations and be involved in the evaluation of the impact on company strategies, processes/procedures of the new, purposed, amended laws and regulations
  • Support the maintenance of the QM system and the interconnection of its different process
  • Develop standard operation procedures, documents, records, forms, and work instructions to maintaining Definiens compliance program. Work with process owners and take initiative in the development, implementation, review and improvement of policies and procedures and assess the effectiveness of the suggested changes.
  • Conduct Quality System Internal Audits.
  • Manage tasks of Document Control at Definiens
  • Support and implementation of the daily tasks of Quality Management regarding releases, CAPAs, change management, complaints, quality documentation
  • Support the Senior Manager Quality and Regulatory in compliance activities
  • Provide consulting on SOP compliance, planned and unplanned deviation to other departments
  • Release, review and approve all QMS documentation, compliant with ISO 13485
  • Provide management with regular reports regarding compliance status, specific action items, problems and opportunities. Monitor and report QMS organization performance
  • Support External Audits

 

Qualifications:

  •  Bachelor's Degree required; scientific discipline is ideal. Advanced scientific degree PhD; Master's is helpful but not required
  • 4+ years demonstrated experience in Quality Management in a regulated Medical Device industry or more than 5 years work in laboratories, pharma or hightech companies
  • Demonstrate relevant experience and knowledge in quality management
  • Profound knowledge of ISO 13485, 21 CFR Part 820 and IVDR
  • Demonstrated strategic thinking and ability to integrate strategies into actionable plans
  • Demonstrate knowledge on risk management, design verification and validation, software lifecycle and other directives applicable to Medical and in vitro diagnostic devices
  • Experience managing multiple products simultaneously and different stages of the product lifecycle is highly desirable
  • Demonstrates strong written, verbal, and interpersonal communication English skills
  • Ability to travel as required (may include international travel)
  • Extensive knowledge of ISO 13485
  • Ability to work in a fast-paced and growing company
  • Ability to effectively communicate with all levels of employees and a service orientation.
  • Ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and keeps attention to detail
  • Ability to ask detailed questions in order to collect business process information and best practices, and effectively work with others in a positive and collaborative manner
  • Team player with excellent interpersonal and social skills
  • Excellent presentation skills
  • Good problem solving ability

 

We offer: 

This is a challenging and rewarding position within a pioneering company that works with cutting edge technologies. We offer a modern, creative and international working environment with great colleagues and team spirit in the center of Munich and excellent working conditions with ongoing professional development opportunities.

 

For more information please visit: www.definiens.com

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