Quality Engineer - Complaint & Risk Leader (On-Site)

MED Medtronic Inc; Santa Ana (CA); On-site; USD 79,000 - 119,000; Full time

Job summary

Medtronic in Santa Ana, CA is seeking a qualified professional to oversee complaint investigations in a highly regulated medical devices environment. This on-site role requires four days in the office and does not sponsor visas.

You will collaborate across regulatory, R&D, clinical, and manufacturing teams to ensure product safety and compliance, with a competitive salary and comprehensive benefits described in the posting.

Qualifications

• Bachelor’s degree in engineering, health science, or a technical discipline.
• Minimum of 2 years of work experience in engineering or science, OR advanced degree in engineering, science, or technical discipline with 0years of work experience.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the 8 CFR 214.2(h)(4)(iii)(A) is required.

Responsibilities

• Lead complaint investigations.
• Trend complaint data and identify patterns.
• Evaluate negative trends and potential risks.
• Assess risk to released products; support field actions and explants analysis.
• Collaborate with customer quality, clinical affairs, medical safety, R&D, and manufacturing on investigations.
• Prepare responses to regulatory queries with regulatory affairs.
• Partner with design assurance on risk analysis using DFMECA and related docs.
• Maintain periodic safety update report (PSUR) with cross-functional teams.
• Develop solutions for complex issues and improve processes.
• Prioritize timely presentation of issues and report to leadership.

Education

Bachelor’s degree in engineering, health science, or a technical discipline

Job description

Medtronic in Santa Ana, CA is seeking a qualified professional to oversee complaint investigations in a highly regulated medical devices environment. This on-site role requires four days in the office and does not sponsor visas.

You will collaborate across regulatory, R&D, clinical, and manufacturing teams to ensure product safety and compliance, with a competitive salary and comprehensive benefits described in the posting.