Quality Engineer
Job Type: W2, 2-year Contract
Location: Plymouth, Minnesota 55441
Pay Rate: $40 – $43 an hour
Position Summary:
We are seeking a Quality Engineer to support our internal Quality Management System (QMS) initiatives. The ideal candidate will have proven experience conducting internal and external audits and a strong working knowledge of regulatory standards including 21 CFR 820, ISO 13485, and Current Good Manufacturing Practices (CGMP).
This role is critical to ensuring compliance across product and QMS documentation and will involve active participation in audit planning, execution, and reporting. The successful candidate will also contribute to general quality engineering tasks and collaborate across teams to uphold quality standards.
Key Responsibilities:
QMS Familiarization:
- Develop a deep understanding of the client’s QMS requirements and apply this knowledge to daily tasks and audits.
Documentation Review:
- Evaluate product and QMS documentation to ensure alignment with internal standards and regulatory requirements.
Audit Management:
- Maintain and update the internal audit schedule.
- Assist in coordinating and communicating audit agendas and timelines.
- Participate in the execution of internal audits.
- Generate detailed internal audit reports summarizing findings and recommendations.
Quality Oversight:
- Review and approve product-related and QMS work products as needed to ensure compliance and quality integrity.
General Quality Engineering Support:
- Perform additional quality engineering duties as required to support the team and organizational goals.
Qualifications:
- Experience with internal/external auditing practices.
- Strong understanding of 21 CFR 820, ISO 13485, and CGMP regulations.
- Familiarity with QMS systems.
- Excellent communication and documentation skills.
- Ability to work independently and collaboratively in a fast-paced environment.