Quality Operations Specialist I
Aequor JD ·www.aequor.com
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Description: Major Accountabilities:
Review and investigate assigned technical and clinical customer complaints. Perform technical investigations and document results per established procedures and timelines.
Supports quality functions pertaining to manufacturing line support and maintenance, including SAP.
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.
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
Years Experience: 2-5 years
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;
Strong computer skills (including Excel)
Demonstrated written and verbal communication skills
Bachelor s Degree in Electrical Engineering or Mechanical Engineering HIGHLY PREFERRED. Other Engineering degrees or Natural Science degrees to be considered with RELEVANT experience in MEDICAL DEVICE TROUBLESHOOTING.
Custom Fields:
Name: Invoice Type
Value: USA-ARL-Staffing-USD
Name: Worker Time Type
Value: Full Time
Name: Workspace
Value: None
Name: Badge ID Required
Value: Yes
Name: System Access Required
Value: Yes
Name: Work Desk Phone Number Required
Value: No
Name: Supervisory Org
Value: Quality Operations - Complaints(Jenny Garciacano)-60001868
Name: Remote Worker
Value: No
Review and investigate assigned technical and clinical customer complaints. Perform technical investigations and document results per established procedures and timelines.
Supports quality functions pertaining to manufacturing line support and maintenance, including SAP.
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.
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
Years Experience: 2-5 years
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;
Strong computer skills (including Excel)
Demonstrated written and verbal communication skills
Bachelor s Degree in Electrical Engineering or Mechanical Engineering HIGHLY PREFERRED. Other Engineering degrees or Natural Science degrees to be considered with RELEVANT experience in MEDICAL DEVICE TROUBLESHOOTING.
Custom Fields:
Name: Invoice Type
Value: USA-ARL-Staffing-USD
Name: Worker Time Type
Value: Full Time
Name: Workspace
Value: None
Name: Badge ID Required
Value: Yes
Name: System Access Required
Value: Yes
Name: Work Desk Phone Number Required
Value: No
Name: Supervisory Org
Value: Quality Operations - Complaints(Jenny Garciacano)-60001868
Name: Remote Worker
Value: No
Frequently asked questions
Who is hiring for the Quality Operations Specialist I role?
Aequor JD is hiring for the Quality Operations Specialist I position, a Shazamme client. Apply directly on the employer's career site.
Where is the Quality Operations Specialist I job located?
The Quality Operations Specialist I role with Aequor JD is based in Irvine, CA, US.
Is the Quality Operations Specialist I role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Quality Operations Specialist I role?
The Quality Operations Specialist I position is aimed at mid-level candidates.
How do I apply for the Quality Operations Specialist I role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.