Senior Design Quality Engineer/ Design Quality Engineer

Job highlights

• . Bachelors Engineering degree with 5-7 years of related experience or Masters degree with 3+ years of related experience -Mechanical/ Electrical/ Electronic or Equivalent Engineering . Engineering Degree or equivalent experience in the medical device industry . 3+ years experience with a medical device company preferably

Job_Description":"

**Senior Design Quality Engineer/ Design Quality Engineer

**Roles Responsibilities

• Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and support Quality Plan design.

• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and all design-related activities during the product/system lifecycle.

• Validates key design inputs like usability, reliability, Performance, supportability, manufacturability, localizability, security, Privacy, serviceability, sustainability, and costs.

• Performs assessment of product quality performance and post-market product quality analysis.

• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers, or design teams) and initiates field actions when enquired.

• Ensure compliance requirements are met during design reviews, design Verification, validation, and design transfer.

• Apply and Facilitate design for quality and reliability best practices (FMEA, robust design, VV, RCA, Problem-solving).

  **Qualifications **- Bachelors Engineering degree with 5-7 years of related experience or Masters degree with 3+ years of related experience -Mechanical/ Electrical/ Electronic or Equivalent Engineering

  • Engineering Degree or equivalent experience in the medical device industry

  • 3+ years experience with a medical device company preferably

    **Skill Set

    **- Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.).

    • Experience or understanding of Software or Hardware development, Verification and Validation, Risk management, RCA, Requirements Management, Design, and Usability.

    • Understand Sample Size Determination and Statistical Methods, Safety Risk Management (i.e ISO 14971), and Failure Modes and Effects Analysis (FMEA) / Fault Tree Analysis.

    • Understand a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.

    • Understand the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.

    • Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.

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