The Staff Quality Engineer will manage risk assessments and quality inspections, create documentation, and lead verification testing strategies for product safety in compliance with medical device standards. They will collaborate with engineering and operations teams and mentor junior engineers, focusing on quality data analysis and compliance with GMP and ISO 13485 guidelines.
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%
Top Skills
Programming Language
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