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SQSQA Services

Quality Auditor - Pharmaceutical/Medical Device(m/w/x)

Berlin
from USD 1,700
Full-timeFreelanceOn-siteSenior

Performing supplier quality audits for pharma/medical device manufacturers. 5+ years audit experience, including 21 CFR 210/211 and ISO 13485, required. Coordination of audit schedules and conflict de-escalation skills.

Requirements

  • 5+ years hands-on audit experience in pharma/medical device/biologics
  • Lead auditor in at least 10 audits
  • Direct audit experience to 21 CFR 210/211, EU Vol 4, ISO 13485, 21 CFR 820
  • Strong communication and writing skills
  • Ability to deescalate workplace conflicts
  • Adaptability to new technology and software
  • Willingness to travel regionally
  • Direct audit experience to ISO 17025, ISO 15378, animal health
  • ISO certifications (advantageous)

Tasks

  • Perform supplier quality audits
  • Assure quality in supply chains
  • Coordinate audit schedules
  • Prepare for supplier audits
  • Execute supplier audits
  • Deliver audit findings
  • Utilize regulatory knowledge
  • Respond to content team
  • Write audit reports

Work Experience

  • 5 years

Education

  • Vocational certificationOR
  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • 21 CFR part 210/211
  • EU Vol 4
  • ISO 13485
  • 21 CFR 820
  • ISO 17025
  • ISO 15378
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SQA Services and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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