Job Description: Quality engineer experienced with internal or external auditing to internal QMS requirements; understands 21 CFR 820 ISO 13485 and CGMP Regulations.
Contract duration would be 2 years.
Responsibilities: - Understand Clients QMS requirements at a detail level.
- Review Product and QMS documentation to evaluate compliance.
- Maintain an internal audit schedule.
- Assist in communicating internal audit agendas and scheduling.
- Participate in internal audits.
- Generate Internal Audit reports.
- Review and approve product and QMS work products as required.
- General Quality Engineer tasks as required.