Quality Engineer II

Overview

Quality Engineer II provides design quality engineering support for medical device product development and sustaining engineering activities, partnering with cross-functional teams across the product lifecycle.

What you'll do

• Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Ensure product development projects and design changes comply with FDA Quality System Regulations, European Union Medical Device Regulation (EU MDR), and internal quality requirements.
• Partner with cross-functional teams to develop and maintain risk management documentation, including Risk Management Plans, Hazard Analyses, Design Failure Mode and Effects Analysis (DFMEA), and Risk Management Reports in accordance with ISO 14971.
• Support design verification and validation activities through development and review of plans, protocols, reports, testing strategies, and compliance assessments.
• Review Design History Files (DHF) and Technical Files for compliance with applicable regulations, standards, and quality requirements.
• Support successful transfer of products into manufacturing through process validation activities, including Process Failure Mode and Effects Analysis (PFMEA), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop quality system templates, training materials, and guidance related to design controls, risk management, quality system regulations, and applicable standards.
• Participate in internal and external audits and provide quality engineering guidance across project teams and organizational functions.

What you'll need

• Bachelor's degree in Mechanical Engineering with 5+ years of overall experience, including 3+ years of quality engineering experience in medical device, regulated manufacturing, or healthcare industries.
• Experience with medical device Design Controls, Risk Management, and product development activities.
• Experience supporting ISO 14971 risk management activities, including Risk Management Plans, Hazard Analyses, and Design Failure Mode and Effects Analysis (DFMEA).
• Knowledge of FDA Quality System Regulation, ISO 13485, EU MDR, IEC 60601, 21 CFR Part 820, and 21 CFR Part 11.
• Experience using statistical tools and methodologies, including Minitab, sampling plans, hypothesis testing, Analysis of Variance (ANOVA), Gauge Repeatability and Reproducibility (GR&R), and related statistical techniques.

Nice to have

• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), or Certified Reliability Engineer (CRE) certification.
• ISO 9001 or ISO 13485 Internal Auditor or Lead Auditor certification.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with DMAIC or Design for Six Sigma (DFSS)/DMADV methodologies.
• Experience acting as a Risk Management or Design Quality subject matter expert within cross-functional product development teams.

Details

• Location: Hyderabad, India.
• Work mode: Flex work arrangement.
• No travel required.
• Eligible for the Medtronic Incentive Plan (MIP), a short-term incentive.