Quality Engineer Sustaining

Job Title: Quality Engineer Sustaining
Company: Intellectt Inc.
Location: Greater Salt Lake City, Utah
Employment Type: W2 Contract
Pay Rate: $40 $45/hr
Work Arrangement: Onsite

Job Summary

Seeking a Quality Engineer to support sustaining operations in a regulated medical device manufacturing environment. The engineer will work with Quality, Manufacturing, and Engineering teams to investigate product and process issues, resolve nonconformances, and support continuous quality improvement.

Key Responsibilities

• Investigate nonconformances and document Nonconformance Reports (NCRs).

• Perform root cause analysis and support Corrective and Preventive Action (CAPA) activities.

• Collaborate with Manufacturing and Engineering teams to resolve product and process quality issues.

• Support quality studies, collect and analyze data, and document investigation findings.

• Help improve inspection methods, testing processes, and manufacturing quality controls.

• Participate in test method development and validation activities.

• Maintain accurate quality records in accordance with applicable procedures and quality system requirements.

Required Qualifications

• Engineering degree required.

• 2 6 years of Quality Engineering experience in the medical device industry.

• Hands-on experience with nonconformance investigations, NCRs, CAPAs, and root cause analysis.

• Working knowledge of quality system processes in a regulated manufacturing environment.

• Strong documentation, problem-solving, and cross-functional collaboration skills.

Preferred Qualifications

• Experience with test method development and validation.

• Experience with automated visual inspection, dimensional inspection, or other advanced inspection technologies.

• Familiarity with electronic quality documentation systems, electronic Device History Records (eDHRs), or Manufacturing Execution Systems (MES).

Key Skills: Medical Device Quality Engineering, Sustaining Engineering, Nonconformance Investigations (NCR), CAPA, Root Cause Analysis (RCA), Quality System Management.

Recruiter Contact:

Rudra Prasad Kunnath
Email:
Phone:

Benefits: Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.
• Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.