Quality Engineer II — Post-Market Compliance (On-Site)
Regulatory Jobs
Mach aus dieser Rolle ein Bewerbungsgespräch — ein Lebenslauf und ein Anschreiben, die darauf ausgerichtet sind, was dieser Arbeitgeber sucht.
Benefits dieser Stelle
Zusammenfassung
Medtronic in Santa Ana, CA seeks a Quality Engineer II to own post‑market surveillance, including complaint investigations, data trending, and regulatory submissions. The role requires on-site presence four days a week and involves cross‑functional collaboration with R&D, regulatory affairs and manufacturing.
A bachelor’s in engineering/health science is required; advanced degrees are a plus. Responsibilities include leading investigations, preparing regulatory responses, maintaining PSURs, and
Qualifikationen
- Bachelor's degree in engineering, health science or technical discipline is required.
- 2+ years of work in engineering or science, or an advanced degree with 0 years experience.
- Experience with post-market quality, complaint investigations and regulatory interactions is desirable.
Aufgaben
- Lead complaint investigations and periodic data trending to assess risks.
- Collaborate with cross-functional teams for thorough investigations.
- Prepare responses to regulatory queries for registrations/submissions.
- Partner with design assurance on risk analysis and PM surveillance plans.
- Own PSURs and drive improvements to processes and systems.
Kenntnisse
Ausbildung
Tools
Jobbeschreibung
Medtronic in Santa Ana, CA seeks a Quality Engineer II to own post‑market surveillance, including complaint investigations, data trending, and regulatory submissions. The role requires on-site presence four days a week and involves cross‑functional collaboration with R&D, regulatory affairs and manufacturing.
A bachelor’s in engineering/health science is required; advanced degrees are a plus. Responsibilities include leading investigations, preparing regulatory responses, maintaining PSURs, and
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