Senior Quality Assurance Specialist
6 days ago
Seeking a Senior Quality Assurance Specialist to join Millenniumsoft in Tempe, AZ.
Estimated Salary: $90,000 - $110,000 per year
We are looking for a highly skilled and experienced Quality Assurance Engineer to lead the quality initiatives of our Medical Device Company clients.
The ideal candidate will have a strong background in cGMP regulations and experience with Quality Notifications, Complaints, Deviation/Waivers.
This is a contract position on W2 requiring US Citizens or GC holders. The duration is 5+ months with 40 hours/week, primarily working first shift.
Key Responsibilities:
- Review and assess Quality Notifications, Complaints, Deviation/Waivers for assigned product lines.
- Ensure adherence to internal Quality Policies and related FDA/GMP guidelines.
- Investigate manufacturing issues and provide data/input on technical projects.
- Develop solutions to moderate scope and complexity problems using policies and procedures for guidance.
Requirements:
- BS or BA in related field with up to 2 years of experience, or MS with no experience required.
- Typical degree in Mechanical, Electrical, Industrial, Biomedical Engineering, Biological Sciences, Chemistry, Computer Science, or other related field.
- Demonstrate a working understanding of pertinent Quality Systems Regulations.
- Proven ability to use Microsoft programs and willingness to learn other systems.
- Utilize TRACKWISE software as an advantage.
If you're a motivated and detail-oriented professional seeking a challenging role in Quality Assurance, we encourage you to apply.
A BS or higher in a relevant field along with up to two years of experience can be considered suitable for this senior-level position.
This mid-to-senior level position requires candidates to demonstrate expertise in several areas including cGMP regulations, tracking software, and excellent communication skills.
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