Quality Engineer Equipment Validation

Job Title : Quality Engineer Equipment Validation
Company: Intellectt Inc.
Location: Pendleton, SC
Employment Type: Contract

Job Summary:
Seeking a Quality Engineer to support equipment and special process validation for medical device manufacturing. This role involves reviewing and executing validation protocols, compiling validation packages, developing SOPs, and investigating deviations. Equipment includes laser marking systems, laser welders, and grinders used to manufacture metal and ABS/PEEK instruments and implants.

Key Responsibilities:

• Lead and coordinate validation execution with Operations and Engineering teams.
• Review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
• Execute validation protocols for laser marking, laser welding, grinding, and related manufacturing equipment.
• Inspect and document validation results, identify discrepancies, and provide feedback to project teams.
• Compile completed validation packages, ensuring records are accurate, complete, and ready for review.
• Develop and update SOPs, work instructions, forms, and templates.
• Lead and write validation-related deviation investigations.
• Support nonconformance investigations and corrective and preventive actions (CAPAs).
• Ensure validation activities follow approved procedures and applicable GMP and quality requirements.

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.

Relevant Equipment Experience:

• Laser marking systems
• Laser welding equipment
• Grinders
• Equipment used to manufacture metal or ABS/PEEK medical instruments and implants

Pay Scale:

• Anticipated hourly pay range: [$55/hour on W2]

Benefits
Employees hired into this position are eligible for the following 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 paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO is provided other than that 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.

Contact to Apply:
Name: Pavani Samboju
Email:
Phone: 732 993 4972
INTELLECTT INC