Quality Engineer II

• Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards.
• Participate on cross-functional teams to develop product risk management file (risk management plan, Hazard Analysis, DFMEA, and risk management report) as per ISO 14971.
• Acts as the subject matter expert on risk management for one or more products/platforms.
• Previous experience working in a cross-functional team environment.
• Familiar with statistical software tools (Minitab, Stat Graphics)
• Familiar with ISO 13485, ISO 14971, IEC 60601 and product specific industry standards.
• Hands-on experience on EU MDR.
• Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Assist in creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
• Participate and provide input to training on department / division procedures and policies.
• Participate when appropriate in audits
• Independently develop test strategies for new, pre-concept features in development.
• Develop templates and trainings based on the quality system regulations, applicable standards and guidance.
• Independently review all deliverables to ensure compliance with development process and the standard.
• Deliver presentations to the QA organization on status and issues of assigned projects.

• Hands-on experience on Risk Management, Design Controls for Medical Devices.

• B E or B. Tech in Mechanical Engineering
• Minimum 3-5 years of quality engineering experience or equivalence and overall 5-8 years of experience.
• Previous experience working in a cross-functional team environment.
• Familiar with statistical software tools (Minitab, Stat Graphics)
• Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
• Good verbal and written communication skills including protocol / report development and technical presentations.
• Fair Knowledge in Risk Management
• Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.
• Familiar with DMAIC or DMADV(DFSS) methodologies.

• ISO 13485 Internal Auditor / Lead Auditor Certification
• Lean Six Sigma Green Belt.

Medtronic