Hello,
Greetings of the day!!!
One of our medical device clients is looking for the role of
QA Technician if the job duties suit your profile please share your updated resume with srilatha@intellectt.com or call 732-790-5303
Role: QA Technician
Location: Scarborough, ME
Job Description
- Conduct product testing to support complaint investigations and stability verification
- Generate, document, and asses product testing results
- Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production.
- Collaborate with Manufacturing and QC groups to resolve issues in quality records
- Initiate and author Quality Incidents (QI)
- Conduct spot-check inspections/audits of production operations
- Write, review and approve Standard Operating Procedures (SOPs) as necessary
- Assist in supporting the Document Control program, record retention areas, and sample retention areas
- Communicate quality issues to QA Management in a timely manner
- Log returned instruments from the field.
- Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
- Inspect returned instruments for damage and perform basic investigation and document results prior to second-level processing.
- As necessary, process instrument documentation for return to the repair facility, and pack instruments as required.
Education And Experience
- Bachelor's Degree in Biology, Chemistry, Life Science, or related technical field or the equivalent combination of experience and education.
- 3+ years in a Quality Assurance role within the medical device industry.
Competencies
- Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)
- Ability to perform Immunological Assays and NEAR Molecular assays
- Knowledge of site software for inventory management, Document Control, Quality incident tracking, and Customer Complaint tracking
Srilatha
Technical Recruiter
Intellectt Inc
srilatha@intellectt.com
Desk Number: 732-412-6999 Ext: 351
Direct Number: 732-790-5303
517 Route 1 South, Suite 1115 Iselin, NJ 08830.