Quality Engineer – Equipment Validation

Job Title: Quality Engineer Equipment Validation
Company: Intellectt Inc.
Location: Pendleton, SC
Employment Type: W2 Contract
Pay Rate: $45/hr on W2
Work Arrangement: Onsite

Job Description:
Intellectt Inc. is seeking a Seeking a Quality Engineer with 2+ years of GMP-regulated medical device experience to execute equipment and process validation, review IQ/OQ/PQ protocols, prepare validation documentation, develop SOPs, and manage deviations and CAPAs.

Key Responsibilities:

• Execute and review equipment validation protocols and reports.
• Support validation of laser marking, laser welding, and grinding equipment.
• Prepare validation packages, SOPs, and work instructions.
• Investigate deviations, nonconformances, and CAPAs.
• Ensure compliance with GMP and quality procedures.

Required Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related discipline.
• At least 2 years of experience in the GMP-regulated medical device industry.
• Hands-on experience writing and executing validation protocols.
• Knowledge of equipment qualification and IQ/OQ/PQ documentation.
• Strong technical writing, documentation, organizational, and project coordination skills.
• Ability to communicate effectively with cross-functional teams and manage multiple priorities.
• Strong attention to detail and a compliance-focused approach.

Required Skills: Medical Device Validation, IQ/OQ/PQ, Validation Protocols, Equipment Qualification, CAPA/Deviation Management.

Recruiter Contact
Soundarya Kondra
Email:

soundarya.kondra@intellectt.com

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.