What are the responsibilities and job description for the QA Technician II (Medical Device) position at TekOne IT Services Pvt. Ltd.?
Role: QA Technician II (Medical Device)
Location: Westbrook, ME
Duration: 4 Months on W2
Shift Timings: 8:00 am - 4:30 pm (Monday - Friday)
Responsibilities
Location: Westbrook, ME
Duration: 4 Months on W2
Shift Timings: 8:00 am - 4:30 pm (Monday - Friday)
Responsibilities
- Quality System Management:
- Review production and finished goods batch records for accuracy.
- Conduct spot-check inspections/audits and participate in the internal audit program.
- Write, review, and approve SOPs; assist with validation/test protocols.
- Test and report on complaint and stability samples.
- Author Deviations and Quality Incidents (QI); may administer calibration, document control, and quality records programs.
- Train new and current QA personnel.
- Change Control Management:
- Document change management; maintain quality system records for design change projects.
- Manage labeling process, including proofreading and implementing label changes.
- Assist with implementation of product changes and manage assigned Design Change projects.
- Bachelor's Degree in Chemistry, Biology, Life Science, or related field, or equivalent experience.
