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Quality Operations Specialist
2 months ago
Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global medical device company in Irvine, CA.
Job Title: Quality Operations Specialist (Contract)
Pay Rate Range: $30/hr - $36/hr (W-2)
Initial Duration: 18 months
Major Accountabilities:
- Review and investigate assigned technical and clinical customer complaints. Perform technical investigations and document results per established procedures and timelines.
- Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation.
- Assist complaint intake group through review and verification of initial complaint coding.
- Monitor post-market and manufacturing product performance through evaluation and trending of customer complaints, service calls, and manufacturing rejections. Ensure that appropriate corrective actions are implemented to address the root cause of trending issues.
- Supports quality functions pertaining to manufacturing line support and maintenance, including SAP.
- Support and coordinate product/process improvements through collaboration with cross-functional teams (Quality, Manufacturing, R&D, Supply Chain, Finance, etc).
- Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices.
Must Haves:
- Bachelor’s Degree in Biomedical, Natural Sciences, Engineering or related fields
- Strong computer skills (including Excel)
- Demonstrated written and verbal communication skills
Preferred Qualifications:
- Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc.)
- Familiarity with medical device complaint files and quality records
- Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard
- SAP preferred, but not required
