Quality Engineer – Medical Device

Location

Pendleton, South Carolina, United States

Salary

Not specified

Company

Akash pawar

Job description

• Role & Company / Project Overview Stark Associates LLC is hiring a Quality Engineer with experience in medical device manufacturing and validation for a W-2 contract position located in Pendleton, South Carolina. • Key Responsibilities & Daily Duties - Lead and execute equipment and process validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) - Oversee quality assurance and validation activities specifically involving laser marking and laser welding processes - Ensure all manufacturing and quality documentation complies with Good Manufacturing Practice (GMP) regulations and medical device standards - Identify process deviations, support root cause investigations, and implement appropriate corrective and preventive actions (CAPA) • Required Qualifications, Skills & Experience - Proven engineering and quality experience within a GMP-regulated medical device manufacturing environment - Hands-on expertise in validation protocols (IQ, OQ, PQ) - Practical experience with laser marking and laser welding technologies - Strong understanding of medical device quality management systems and regulatory standards • Working Hours, Shifts & Location Details - Location: Pendleton, South Carolina - Employment Type: W-2 Contract - Assignment Duration: Approximately 4 months - Start Date: November 2, 2026 • Compensation & Benefits - W-2 contract assignment • Application Instructions Interested candidates who meet the qualifications are encouraged to submit an updated resume for immediate consideration.