Quality Operations Specialist I

Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation. Monitor post-market and manufacturing product performance through evaluation and trending of customer complaints, service calls, and manufacturing rejections.

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