M
Hiring companyMedtronic
Verified today
Quality Engineer II
Nanakramguda, Hyderabad, India Full-time Hybrid
About the role
Medtronic Engineering team builds safe, reliable medical devices and ensures compliance with global regulatory standards. The Quality Engineer II drives risk management, conducts design reviews, and leads post‑market surveillance activities, collaborating with cross‑functional groups to maintain product safety. Hyderabad, India – hybrid work model with on‑site presence as needed.
What you’ll do
- Develop and maintain product risk management files and DFMEA
- Conduct design reviews for manufacturability, reliability, and compliance
- Ensure adherence to FDA QSR, EU MDR, ISO 13485, ISO 14971 standards
- Analyze post‑market data, generate PSURs, and support regulatory submissions
- Lead audits and CAPA/NCMR activities
- Provide training and presentations on quality processes
- Collaborate with regulatory affairs and medical experts
What you’ll bring
- Bachelor's degree in engineering or related field
- 5-8 years of quality systems experience
- Experience with ISO 13485, ISO 14971, FDA QSR (21 CFR Part 820)
- Familiarity with risk management and hazard analysis
- Proficient in statistical tools such as Minitab
- Strong written and verbal communication skills
- Ability to work with global, multicultural teams
Skills
Risk ManagementFDA QSRISO 13485Post Market SurveillanceMinitabCAPADesign ControlsRegulatory Submissions
Benefits
- Competitive salary
- Flexible benefits package
- Short‑term incentive plan