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Quality Technical Specialist   (43324ND)

1. Performs complex inspection tasks to approve incoming product by confirming specification; using precision calipers, micrometers and other measuring devices.
2. Works within the non-conformance system to record discrepancies assists in the review of the non-conformance and to record the results of the Material Review Board (MRB) and associated activities.
3. Reviews device master records, history records and other quality-related documents for accuracy and completeness. Performs first article inspections and release of finished goods to inventory.
4. Performs routine testing of medical devices to replicate customer complaints and whenever applicable, work with the investigator to determine the root cause of the complaint.
5. Performs routine review of repairs to determine if a complaint should be generated and whenever applicable, work with the investigator to determine the root cause of the complaint.
6. Performs inspections, repairs and completes records of repairs for medical devices.
7. Under limited supervision, contacts customers and sales representatives to resolve technical and quality problems and may provide technical support.
8. Creates and deliver quotations for repairs based on historical data and/or company guidelines and procedures.
9. Evaluates and process Return Goods Authorizations (RMA’s) as necessary
10. Participate in FDA, ISO and quality audits.
11. Maintains precision equipment and works with calibration company to ensure calibration is maintained.

MINIMUM QUALIFICATIONS – The qualifications below are the knowledge, skills, and abilities required to do this job. Must be computer literate and be able to clearly communicate verbally and in writing. Proficient in Microsoft Office. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Self-motivation with a sense of task ownership to work and solve problems confidently, cross-functionally, collaboratively and when necessary, independently.
2. Ability to read common technical drawings and documents on mechanical and/or electrical devices.
3. Quality inspection or manufacturing experience, preferably in a regulated environment (FDA, ISO, etc.) that includes engineering drawings and/or specification review experiences.
4. Ability to determine quick and efficient solutions to problems that may arise in the activities of inspection, MRB or repairs.
5. Strong interpersonal and communication skills, including written and verbal skills, and ability to effectively communicate technical issues to people with technical and non-technical backgrounds.
6. Inspection and technical repair experience in the medical device field is highly desired.
7. Some travel may be required.

詳細情報Job Detail

Job Category Other
Position Quality Technical Specialist
Job Order # 43324ND
Salary $ 50K ~ $ 60K or more (non-exempt) + Bonus
Working Location Union City
Hours 8 - 5
Days M -F
Bonus Yes
Parking Yes
Medical Yes
Dental Yes
Holiday Yes
Sick Leave Yes
Vision Yes
401K Yes
Profit Sharing Yes
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