Quality Engineer

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

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

• Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant.
• Ensure documentation and procedures are followed as required by internal Quality Policies and related FDA/GMP guidelines.
• Conducts complaint investigations, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
• BS or BA in related field required with up to 2 years of experience, or MS with no experience required.
• Typical degree in Mechanical or Electrical or Industrial or Biomedical Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.
• Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA).
• Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
• Capable of using Microsoft programs and ability to learn other systems.
• Utilizing TRACKWISE software is an advantage.
• Effective verbal and written communication skills.
• The ability to work in teams and independently with minimal supervision to obtain results as required.
• Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.