What are the responsibilities and job description for the Quality Engineer I-Medical Devices position at TekOne IT Services Pvt. Ltd.?
Job Title: Quality Engineer I-Medical Devices
Location: Westbrook, ME - 04092
Duration: 4 Months (W2)
Shift: 3rd Shift (10 PM - 6:30 AM)
Job Summary: The Quality Engineer I will support manufacturing line quality by ensuring compliance with GMP, GDP, and quality standards. Responsibilities include performing line clearances, shift change activities, set-up and label verification, and contributing to Quality System processes like training, CAPA, and quality audits. The role involves independent documentation, maintaining the Quality System, and providing technical assistance as needed.
Main Responsibilities
Location: Westbrook, ME - 04092
Duration: 4 Months (W2)
Shift: 3rd Shift (10 PM - 6:30 AM)
Job Summary: The Quality Engineer I will support manufacturing line quality by ensuring compliance with GMP, GDP, and quality standards. Responsibilities include performing line clearances, shift change activities, set-up and label verification, and contributing to Quality System processes like training, CAPA, and quality audits. The role involves independent documentation, maintaining the Quality System, and providing technical assistance as needed.
Main Responsibilities
- Perform line clearance and setup verification
- Conduct shift change activities and label verification
- Contribute to training, CAPA, and quality audits
- Document processes and maintain Quality System effectiveness
- Follow EHS policies and procedures
- Bachelor’s degree or equivalent experience; Master’s preferred
- Minimum 2 years of related experience
- Strong technical competency, problem-solving, and organizational skills
- Ability to work independently and in teams, with good interpersonal and critical-thinking skills
