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Quality Auditor - Pharmaceutical/Medical Device(m/w/x)
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
- English – Business Fluent
Tools & Technologies
- 21 CFR part 210/211
- EU Vol 4
- ISO 13485
- 21 CFR 820
- ISO 17025
- ISO 15378
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Quality Auditor - Pharmaceutical/Medical Device(m/w/x)
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
- English – Business Fluent
Tools & Technologies
- 21 CFR part 210/211
- EU Vol 4
- ISO 13485
- 21 CFR 820
- ISO 17025
- ISO 15378
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
SQA Services
Industry
Pharmaceuticals
Description
The company has been a leading provider of managed supplier quality services, offering audits, assessments, and engineering solutions to manufacturers.
Not a perfect match?
- PCI Pharma Services Germany GmbH
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Full-timeOn-siteExperiencedGroßbeeren - PCI Pharma Services Germany GmbH
Qualified Person(m/w/x)
Full-timeOn-siteExperiencedGroßbeeren - W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Full-timeOn-siteSeniorBerlin - LRQA
Food Safety Auditor(m/w/x)
Full-timeFreelanceOn-siteExperiencedBerlin - W.O.M. World of Medicine GmbH
Design Assurance Engineer Medical Devices(m/w/x)
Full-timeOn-siteExperiencedBerlin