Staff Quality Engineer

Work Flexibility: Hybrid

What will you do:

• Risk management, Risk Table creation & Analysis, FMEAs, Quality Inspection procedure, Literature Review, Device Master Record, Design Validation & Quality Training plan.
• Product risk assessment as per ISO14971 and support validation programs for new product development.
• Responsible for initiating, reviewing (Includes Design reviews & Phase Reviews), documenting and approving Engineering Change Orders (ECO s).
• Work with engineering & manufacturing teams to develop robust verification test strategies to ensure product safety and reliability.
• Partners with the operations team to develop and maintain a robust internal and external supply chain. Contribution examples include the performance of supplier audits, risk assessment/mitigation, and coaching.
• Assists and mentors the unit quality engineer in the trending and analysis of quality data (e. g. complaints, Tech Support trouble tickets, Pareto charts, scrap, warranty return rate, etc. ) and provides guidance to address issues as appropriate.
• Authors and reviews procedures to ensure GMP and ISO 13485 compliance.
• Lead product quality related projects. Supports the business in addressing and solving quality problems.

What you need:

Required Qualifications:

• Bachelors or master s in technology or medical software and at least 5 years of relevant experience.
• Exposure to any Programming language & on Software Testing concepts.
• Exposure to Software development life cycle & validation process.
• Able to do risk assessment for medical devices as per ISO 14971.
• Knowledge of IEC 62304, IEC 606061-1, IEC62366 standard.

Preferred Qualifications:

• Strong experience in Documentation, Review & Reporting areas.
• Demonstrated ability to test, review defects and inspect software codes.

Travel Percentage: 50%