What are the responsibilities and job description for the Quality Technician position at ARKRAY FACTORY USA INC?
Summary
Perform returned goods quality control inspection and testing of medical products, as directed by the Quality Systems. Perform testing for complaint investigations, data compilation, and results interpretation.
Duties and Responsibilities
- Complaint Investigations: Review of product batch records for customer complaints; Returns Goods Processing includes Preparation and handling of returned products, perform investigations and diagnostic testing, maintaining returned product storage and disposal
- Prepare product for international shipping, ensuring proper shipment documentation
- Writes procedures, protocols, and reports as necessary to conduct above activities and maintains documentation in compliance with applicable regulatory programs
- Supporting documentation review of quality records as applicable: Initiate document change orders when required; Performs thorough DHR reviews for compliance; Maintenance of documentation in compliance with regulatory requirements (ISO 13485), cGMPs and aid in filing of records
Knowledge and Skills
- 2 years Quality Control experience (Medical Device experience preferred) or 2 years experience in a diagnostic lab or similar environment
- Preferred: Previous receiving and shipping experience, international shipping experience helpful.
- Preferred: Familiarity with urine strip and/or blood glucose diagnostic products
- Knowledge of ISO 13485, QSR 21 CFR Part 820 regulatory requirements
- Need to be detail oriented, understand the importance for complete and accurate documentation (cGMP)
- Must be comfortable with the use of personal computers e.g., Windows based software, Word, Excel, Access and Visual
- Ability to work independently on projects with little supervision
ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities.
Medical, Dental, Vision, 401K with company match, HSA and FSA options.
