Dein persönlicher KI-Karriere-Agent
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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- 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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- 21 CFR part 210/211
- EU Vol 4
- ISO 13485
- 21 CFR 820
- ISO 17025
- ISO 15378
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
SQA Services
Branche
Pharmaceuticals
Beschreibung
The company has been a leading provider of managed supplier quality services, offering audits, assessments, and engineering solutions to manufacturers.
Noch nicht perfekt?
- PCI Pharma Services Germany GmbH
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Vollzeitnur vor OrtSeniorBerlin - LRQA
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