Mitarbeiter Qualitätssicherung at Osbra GmbH
Berlin, Berlin, Germany -
Full Time


Start Date

Immediate

Expiry Date

29 Dec, 26

Salary

75000.0

Posted On

30 Sep, 26

Experience

17 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Information Technology & Services

Description

About the job


QA/RA Manager – Medical DevicesGermany | Competitive salary + Bonus + BenefitsFor an international medical device company in Germany, we are looking for a hands-on QA/RA Manager to take ownership of the Quality Management System and support the organization’s ongoing MDR and ISO 13485 compliance.This is not a people-management role. You will report directly to the Managing Director and have significant ownership and visibility within the organization where you will make an impact!

  • Your ResponsibilitiesOwn, maintain and continuously improve the QMS
  • Ensure compliance with ISO 13485 and EU MDR
  • Lead preparations for an upcoming external audit
  • Maintain quality and regulatory documentation
  • Support internal/external audits and CAPA activities
  • Coordinate Regulatory Affairs activities with the RA Specialist
  • Work closely with R&D and product development
  • Drive continuous improvement across QA/RA processes


  • Your Background2–3+ years' QA/RA experience within Medical Devices
  • Strong ISO 13485 knowledge
  • Good understanding of EU MDR
  • Hands-on QMS experience
  • Experience with audits and regulatory documentation
  • Proactive, pragmatic and comfortable taking ownership
  • Fluent English; German is an advantage


  • What's OfferedCompetitive Salary
  • Bonus
  • Home-office flexibility
  • Fuel/travel expenses - Company car potentially negotiable
  • Supportive, international and family-oriented working environment


Interested in a hands-on QA/RA position with real ownership and direct access to senior management?📩 Apply or contact me confidentially at hello@frontseatpartners.com

… more


Responsibilities

About the job


QA/RA Manager – Medical DevicesGermany | Competitive salary + Bonus + BenefitsFor an international medical device company in Germany, we are looking for a hands-on QA/RA Manager to take ownership of the Quality Management System and support the organization’s ongoing MDR and ISO 13485 compliance.This is not a people-management role. You will report directly to the Managing Director and have significant ownership and visibility within the organization where you will make an impact!

  • Your ResponsibilitiesOwn, maintain and continuously improve the QMS
  • Ensure compliance with ISO 13485 and EU MDR
  • Lead preparations for an upcoming external audit
  • Maintain quality and regulatory documentation
  • Support internal/external audits and CAPA activities
  • Coordinate Regulatory Affairs activities with the RA Specialist
  • Work closely with R&D and product development
  • Drive continuous improvement across QA/RA processes


  • Your Background2–3+ years' QA/RA experience within Medical Devices
  • Strong ISO 13485 knowledge
  • Good understanding of EU MDR
  • Hands-on QMS experience
  • Experience with audits and regulatory documentation
  • Proactive, pragmatic and comfortable taking ownership
  • Fluent English; German is an advantage


  • What's OfferedCompetitive Salary
  • Bonus
  • Home-office flexibility
  • Fuel/travel expenses - Company car potentially negotiable
  • Supportive, international and family-oriented working environment


Interested in a hands-on QA/RA position with real ownership and direct access to senior management?📩 Apply or contact me confidentially at hello@frontseatpartners.com

… more


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