Senior Quality Assurance Specialist

6 days ago


Tempe, Arizona, United States MILLENNIUMSOFT Full time

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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