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 Client’s 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.

• Understand Client’s 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