Quality Auditor – Pharmaceutical/Medical Device (Contract)

About the role

SQA Services is seeking an experienced Pharma Quality Auditor to conduct supplier audits across Germany and neighboring countries. This contract position offers flexibility to accept or decline assignments based on your availability, with each audit lasting 1‑2 days.

Key responsibilities

• Perform on‑site supplier audits at locations within your region of residence.
• Ensure quality compliance for clients in pharmaceutical, medical device, cosmetics, biologics, and animal health sectors.
• Plan, coordinate, execute, and deliver audits according to client and personal schedules.
• Apply regulatory knowledge of ISO, CFR, FDA, and related standards during audits.
• Respond promptly to the Content team with edits or questions on audit reports.
• Prepare and submit audit reports that meet client specifications.

Required profile

• Minimum 5 years of hands‑on audit experience in pharmaceutical, medical device, or biologics industries.
• Lead auditor on at least 10 completed audits.
• Strong written and verbal communication skills.
• Proven ability to de‑escalate workplace conflicts.
• Comfortable adapting to new technology and software.
• Willingness to travel regionally for audit assignments.

Required skills

• Direct audit experience with 21 CFR Part 210/211.
• Direct audit experience with 21 CFR Part 820.
• Knowledge of EU Volume 4 regulatory requirements.
• Familiarity with ISO 13485.
• Familiarity with ISO 17025 (preferred).
• Familiarity with ISO 15378 (preferred).

What we offer

• Pay rate of $1,700 USD per 1‑day audit, covering preparation, travel, audit execution, report writing, and follow‑up questions.
• Flexibility to accept or reject assignments based on personal availability.