Quality Auditor (Pharmaceutical/Medical Device)

Job summary

This role involves conducting supplier quality audits within the pharmaceutical and medical device sectors, primarily in Germany and neighboring countries. The position is contract-based, allowing flexibility in accepting assignments based on personal availability.

Qualifications

• Minimum of 5 years of direct audit experience in pharmaceutical, medical device, or biologics industries.
• Experience as the lead auditor in at least 10 audits.
• Familiarity with regulatory standards including 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820.
• Strong communication and writing skills.
• Proven conflict resolution abilities.
• Adaptability to new technologies and software.
• Willingness to travel regionally.

Responsibilities

Preferred Qualifications

Pay Rate

• Conduct supplier audits at various locations within the assigned region.
• Ensure quality assurance in supply chains across multiple industries including pharmaceuticals and medical devices.
• Plan, execute, and report on audits according to client and personal schedules.
• Utilize regulatory knowledge to guide audit processes.
• Respond promptly to inquiries from the Content team regarding audit reports.
• Experience with ISO 17025, ISO 15378, and animal health audits.
• ISO certifications are advantageous but not required.
• $1,700 USD per day for a 1-day audit, covering preparation, travel, execution, reporting, and client communication until report finalization. Travel expenses are reimbursed at cost with receipts.