Senior Quality Engineer - Post-Market Leader (On-Site)

Regulatory Jobs; Santa Ana (CA); On-site; USD 98,000 - 148,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Employee stock purchase plan

Job summary

Medtronic in Santa Ana, CA, seeks a Senior Quality Engineer to lead post-market surveillance, drive complaint investigations, and partner with Regulatory Affairs, Clinical Affairs, Medical Safety, and R&D to improve device quality.

This on-site role (4 days/wk) emphasizes risk management, PSURs, CAPA, and cross-functional collaboration. Advanced degrees preferred; minimum 4 years experience; sponsorship not provided.

Qualifications

• Bachelor's degree in engineering, health science, or a technical discipline.
• Minimum of 4 years of relevant experience OR Master’s with 2 years of relevant experience OR PhD with 0 years relevant experience.

Responsibilities

• Lead complex post-market quality activities including investigations, trending, and risk assessments.
• Provide technical leadership for post-market surveillance and complaint handling.
• Collaborate with Regulatory Affairs, Clinical Affairs, Medical Safety, R&D, Manufacturing, and Quality to resolve issues.
• Lead development and maintenance of PSURs and post-market regulatory deliverables.
• Mentor engineers and influence quality strategy and problem solving.

Skills

Post-market surveillance

CAPA

Root cause analysis

Cross-functional collaboration

Regulatory liaison

Data analysis

Quality system improvement

Education

Bachelor's degree in engineering/health science/technical discipline

Advanced degree preferred (MS/PhD)

Job description

Medtronic in Santa Ana, CA, seeks a Senior Quality Engineer to lead post-market surveillance, drive complaint investigations, and partner with Regulatory Affairs, Clinical Affairs, Medical Safety, and R&D to improve device quality.

This on-site role (4 days/wk) emphasizes risk management, PSURs, CAPA, and cross-functional collaboration. Advanced degrees preferred; minimum 4 years experience; sponsorship not provided.