Quality Engineer - GMP/ISO Compliance & Investigations

MillenniumSoft Inc; Tempe (AZ); On-site; USD 60,000 - 80,000; Full time

Job summary

MillenniumSoft Inc is seeking a mid-level QA specialist to review Quality Notifications, complaints, deviations and related cGMP activities for assigned product lines in the instrument plant.

Responsibilities include ensuring documentation aligns with Quality Policies and FDA/GMP guidelines, conducting investigations, and contributing data for technical projects. The role requires strong communication, teamwork, and the ability to work with minimal supervision on multiple tasks.

Qualifications

• BS/BA in a related field with up to 2 years experience, or MS with no experience.
• Must understand cGMP, ISO, FDA regulatory expectations.
• Ability to develop solutions within defined policies and procedures.

Responsibilities

• Review and assess Quality Notifications, Complaints, Deviation/Waivers for assigned product lines.
• Ensure adherence to internal Quality Policies and FDA/GMP guidelines.
• Conduct complaint investigations and assist in manufacturing issue investigations.
• Provide data/input on technical issues and projects.

Skills

Verbal and written communication

Teamwork and independence

Detail oriented

Organized

Multi-tasking

Microsoft Office

Quality Systems Regulations

Education

BS/BA in related field

MS in related field (no experience required)

Tools

TRACKWISE

Microsoft Office

Job description

MillenniumSoft Inc is seeking a mid-level QA specialist to review Quality Notifications, complaints, deviations and related cGMP activities for assigned product lines in the instrument plant.

Responsibilities include ensuring documentation aligns with Quality Policies and FDA/GMP guidelines, conducting investigations, and contributing data for technical projects. The role requires strong communication, teamwork, and the ability to work with minimal supervision on multiple tasks.