Quality Systems Engineer I

2 weeks ago


Brooklyn Park, Minnesota, United States Cirtec Medical Full time
Position Overview:

The Quality Systems Engineer I will play a crucial role in maintaining and enhancing the Quality Management System (QMS) at Cirtec Medical. This position is essential for ensuring compliance with industry standards and operational excellence.

Department:
Quality Assurance

Location:
Brooklyn Park, MN

About Cirtec Medical:
Cirtec Medical has been a trusted partner in the medical device industry for over thirty years, specializing in the outsourcing of complex medical devices. Our expertise spans various fields, including neuromodulation, implantable drug delivery, and cardiac rhythm management, among others.

Key Responsibilities:
1. **Corrective and Preventive Actions (CAPA):** Manage the CAPA system, ensuring timely tracking and resolution of issues.
2. **Complaints Investigation:** Conduct thorough investigations of returned materials and customer complaints.
3. **Nonconforming Material Control:** Oversee the identification and management of nonconforming materials, ensuring compliance with traceability and containment protocols.
4. **Supplier Quality Management:** Assist in the qualification of suppliers and the maintenance of the Approved Supplier List (ASL).
5. **Internal Auditing:** Ensure all internal audits are conducted as per schedule, assessing compliance with FDA and ISO 13485 standards.
6. **Documentation Control:** Support local document control systems and assist in maintaining quality documentation.
7. **Quality Metrics Reporting:** Measure and report on quality system metrics, providing insights for continuous improvement.

Qualifications:
- Bachelor’s Degree in a relevant field.
- Familiarity with quality certifications (e.g., ASQ CQT, QCI).
- Experience in Class I, II, or III medical device manufacturing is preferred.
- Proficient in Microsoft Office and database management.
- Strong communication skills in English, both verbal and written.

What We Offer:
- Comprehensive health care programs including medical, dental, and vision coverage.
- Paid time off and opportunities for professional development.
- A supportive work environment focused on employee well-being and career growth.

Work Environment:
The role is primarily office-based, with a moderate noise level. Cirtec Medical is committed to fostering an inclusive workplace that values diversity and equal opportunity for all candidates.
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