Quality Operations Specialist in Irvine, CA

Integrated Personnel Services Limited; Irvine (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Integrated Personnel Services Limited seeks a qualified engineer to review and investigate medical device complaints in Irvine, CA. You will perform technical investigations, document results, and support quality functions including SAP, ensuring timely closure of investigations.

Ideal candidates hold a Bachelor’s in Electrical or Mechanical Engineering, with additional medical device troubleshooting experience.

Qualifications

• 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.

Responsibilities

• 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.
• 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;

Skills

Technical investigations

Root cause analysis

Quality systems

Education

Electrical Engineering (B.E.)

Mechanical Engineering (B.E.)

Other Engineering or Natural Science with medical device troubleshooting experience

Tools

SAP

Job description

• 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.
• 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;

Education:

• 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.