Quality Engineer II

Job Summary

As a Quality Engineer II, you will provide design quality engineering support for medical device product development and sustaining engineering activities. The role is responsible for facilitating the application of design controls, risk management, design verification and validation, and regulatory compliance activities while partnering with cross-functional teams throughout the product lifecycle. The position is based in Hyderabad.

Responsibilities

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.

Required Qualifications

Bachelors 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 (GRR), and related statistical techniques.

Preferred Qualifications

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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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