Quality Engineer - QMS & Internal Audits (Contract)

DivIHN Integration Inc; Minneapolis (MN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading quality assurance company is seeking a Quality Engineer in Plymouth, MN. The ideal candidate has experience with internal or external auditing to QMS requirements and knowledge of regulations such as 21 CFR 820 and ISO 13485. Responsibilities include evaluating compliance, maintaining audit schedules, and participating in audits. This contract position is ideal for individuals with a mid-senior level of experience in quality assurance.

Qualifications

• Experience with internal or external auditing to QMS requirements.
• Knowledge of 21 CFR 820, ISO 13485, and CGMP Regulations.

Responsibilities

• Understand 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.

Skills

Auditing experience

Knowledge of 21 CFR 820

Familiarity with ISO 13485

Understanding CGMP Regulations

Job description

A leading quality assurance company is seeking a Quality Engineer in Plymouth, MN. The ideal candidate has experience with internal or external auditing to QMS requirements and knowledge of regulations such as 21 CFR 820 and ISO 13485. Responsibilities include evaluating compliance, maintaining audit schedules, and participating in audits. This contract position is ideal for individuals with a mid-senior level of experience in quality assurance.