Quality Operations Specialist I: Device Troubleshooter

Merck & Co.; Irvine (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Merck & Co. in Irvine, CA seeks a Quality Engineer to review and investigate medical device complaints and document results per procedures and timelines.

You will support manufacturing lines, perform hands-on troubleshooting, and coordinate cross-functional improvements with Quality, Manufacturing, R&D, and Supply Chain. The role requires 2–5 years of experience and a Bachelor's degree in Electrical or Mechanical Engineering (or related field with relevant medical device troubleshooting).

Qualifications

• 2–5 years of experience in medical device quality or related role.
• Bachelor's degree in Electrical or Mechanical Engineering.
• Experience with medical device troubleshooting.
• Familiarity with FDA regulations (21 CFR Part 820/803) and ISO 13485.
• Strong Excel skills and written/verbal communication.

Responsibilities

• Review and investigate assigned technical and clinical customer complaints.
• Perform technical investigations and document results per 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 compliance with FDA, ISO 13485 and other regulatory requirements.
• Coordinate product/process improvements with cross‑functional teams (Quality, Manufacturing, R&D, Supply Chain, Finance).

Skills

Excel

Communication skills

Regulatory knowledge

Medical device troubleshooting

Education

Electrical Engineering

Mechanical Engineering

Other engineering or natural science with relevant experience

Tools

SAP

Job description

Merck & Co. in Irvine, CA seeks a Quality Engineer to review and investigate medical device complaints and document results per procedures and timelines.

You will support manufacturing lines, perform hands-on troubleshooting, and coordinate cross-functional improvements with Quality, Manufacturing, R&D, and Supply Chain. The role requires 2–5 years of experience and a Bachelor's degree in Electrical or Mechanical Engineering (or related field with relevant medical device troubleshooting).