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Sr. Quality Engineer

Karwell Technologies

  • Santa Clara, CA
  • 30+ days ago

    Highlights

    Medical Device, ISO 13485, FDA, 21 CFR Part 820, CAPA, NC, Complaint Handling, Post Market Surveillance, PMS, MDR, MDD, Risk Management, ISO 14971, FMEA, DOE, QMS, IQ/OQ/PQ, Regulatory Compliance, Quality Engineer, Medical Device Quality. The ideal candidate will have hands-on experience in quality systems, risk management, complaint handling, post-market surveillance, and regulatory compliance within the medical device industry.

    Numbers & Facts

    LocationSanta Clara, CA

    Description

    Job Description:
    • We are seeking an experienced Sr. Quality Engineer with strong expertise in Medical Device Quality and Regulatory Compliance. The ideal candidate will have hands-on experience in quality systems, risk management, complaint handling, post-market surveillance, and regulatory compliance within the medical device industry.
    • This role will support product development, manufacturing, and quality assurance activities to ensure compliance with industry regulations and standards.
    Responsibilities:
    • Lead design transfer and production support activities while ensuring compliance with FDA and ISO 13485 requirements.
    • Support manufacturing readiness and quality initiatives across product development programs.
    • Manage quality activities for assigned product components/subassemblies to ensure design integrity and manufacturability.
    • Investigate non-conformances using root cause analysis and drive CAPA activities within the Quality Management System.
    • Develop and maintain FMEAs, support risk mitigation efforts, and lead issue resolution activities.
    • Support qualification activities including IQ/OQ/PQ.
    • Identify and implement compliant solutions for engineering and production challenges.
    • Maintain and improve Quality Management System (QMS) processes.
    • Collaborate with cross-functional teams including Engineering, Manufacturing, Operations, and Quality.
    • Interpret and apply medical device regulations and quality standards throughout the product lifecycle.
    • Support internal, external, and regulatory audits and ensure timely closure of audit findings.
    Requirements:
    • Bachelor's degree in mechanical engineering or a related field.
    • ASQ CQE certification is preferred.
    • Minimum 6 years of experience in the Medical Device industry.
    • Strong understanding of Medical Device Quality Systems and regulatory requirements.
    • Hands-on experience with ISO 13485:2016/2019 and 21 CFR Part 820.
    • Experience in Complaint Handling and Post Market Surveillance (PMS) activities.
    • Knowledge of global Medical Device Regulations including MDD/MDR.
    • Experience managing Non-Conformance (NC) processes, CAPA, and internal/external audits.
    • Strong background in Medical Device Risk Management (ISO 14971).
    • Experience with Application, Process, Design, and System FMEA methodologies.
    • Proficiency in statistical tools and techniques, including Design of Experiments (DOE).
    • Ability to perform descriptive and non-parametric statistical analyses.
    • Experience using advanced statistical methods for reliability analysis and data-driven decision making.
    Preferred Skills:
    • Experience working in highly regulated environments.
    • Strong problem-solving and analytical skills.
    • Excellent communication and stakeholder management abilities.
    • Ability to manage multiple projects and priorities simultaneously.
    • Experience working with cross-functional teams in a fast-paced environment.
    • Keywords:
    • Medical Device, ISO 13485, FDA, 21 CFR Part 820, CAPA, NC, Complaint Handling, Post Market Surveillance, PMS, MDR, MDD, Risk Management, ISO 14971, FMEA, DOE, QMS, IQ/OQ/PQ, Regulatory Compliance, Quality Engineer, Medical Device Quality.

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