Senior Manager (m/f/d) RA/QA
Varian Medical Systems Inc
Munich, Germany
vor 13 Std.

Job Description

  • Ensures establishment and maintanance of Quality System according to applicable government regulations and standards e.
  • g. ISO 13485, 21 CFR 820 QSR, MDD 93 / 42 / EEC

  • Supports project managers on optimal use of RA / QA resources within the projects e.g. regarding product risk management according to ISO 14971
  • Provides RA / QA support of Engineering teams responsible for developing medical device software in compliance with IEC 62304 Medical device software -
  • Software life-cycle processes

  • Supports Regulatory Affairs regarding regulatory submissions e.g. 510(k) submissions containing medical device software
  • Is a member of the management team and the Management Representative according to ISO 13485
  • Is accountable for reporting on the performance of the overall Quality System
  • Coordinates the forum for conducting management review and collects data for management review
  • Manages FDA inspections, the CAPA program, and the overall audit program including internal, supplier, and external audit (e.g. TUV)
  • Coordinates and performs quality training
  • Defines goals and objectives and measures employee performance against defined objectives and within budget
  • Job Requirements

  • Bachelor's Degree in Computer Science, Engineering or related technical field required. Masters Degree or equivalent preferred
  • Ideally 10 years industry experience working for multinational medical device manufacturer(s) (or similar regulated industry)
  • 8-10 years management experience or supervisory equivalent providing leadership to the team as well as internal and external stake holders
  • Ability, competence, and confidence to lead people
  • Effective interpersonal and communication skills
  • Sound knowledge and working experience of Quality management system, standards and government regulations applicable to medical devices e.
  • g. ISO 13485, 21 CFR 820 QSR, MDD 93 / 42 / EEC, EU MDR

  • Professional certification is desirable (i.e. SQA-Software Quality Assurance, CQM-Certified Quality Manager)
  • For further information about this vacancy please contact our recruiter : Deniz.Guergen

    Become part of our team

    At Varian, our culture is centered on fostering the creative potential of every employee through teamwork and collaboration.

    Our technologies touch millions of lives every day, and this inspires us to do our best work every day. By using your talent, ambition and creativity, you can build a career that allows you to make a real difference in people’s lives.

    You’re just one click away from the most impactful work you’ll ever do. Apply now and join our mission to help save lives.

    Someone, somewhere, will be glad you did.

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