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    Quality Engineer II - Newport Beach, United States - Renata Medical

    Renata Medical
    Renata Medical Newport Beach, United States

    2 weeks ago

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    Description

    Quality Engineer II

    Renata Medical

    Newport Beach, CA

    From $78,000 a year

    Full-time

    Position Overview

    Renata Medical is seeking an experienced quality engineer to develop critical functions for commercial pediatric cardiovascular medical devices. The role involves managing a diverse range of responsibilities related to implementation and maintenance of the quality management system. This candidate will report directly to the Director of Quality and will play a pivotal role in developing new devices in the pediatric cardiology space and ensure the safety and efficacy of those devices. Renata is a fast-paced startup company that will rely on a motivated candidate able to work with a small team, embrace new challenges, and develop a strong quality system to support development and commercial goals.

    Quality Activities

    • Responsible for developing test methods and documenting protocols/reports to verify and validate device design, process, sterilization, shelf-life, biocompatibility, distribution, and others.
    • Responsible for investigating CAPAs, SCARs, Product Complaints, Non-Conforming Material Reports, RGAs and other QA processes and identifying and implementing effective corrective and preventive actions.
    • Performs trend analysis and establishes corrective/preventive actions as required.
    • Responsible for set-up and validation of test methods, procedures and sampling plans for inspection and testing of finished products.
    • Responsible for conducting hazard analysis and ensuring design and process FMEAs are conducted per ISO
    • Responsible for initiation and approval of change orders (COs) with proper documentation of change, reasons and justifications.
    • Responsible for monitoring supplier quality.
    • Assists in supplier audits to ensure continued compliance and acceptability.
    • Performs statistical analysis of product testing data.
    • Performs robust root cause and corrective action analysis.
    • Performs internal audits per the audit plan and implement/assist in implementing corrective and preventive actions.
    • Recommends improvements in quality system to ensure that the quality system is efficient and effective controls are in place to minimize risk.
    • Follows and enforces compliance to the Companys quality system and regulatory body requirements per ISO 13485/FDAs QSRs.
    • Responsible for providing support to achieve quality objectives.
    • Completes projects in a timely manner and consistent with corporate objectives.
    • Identifies needs and document SOPs, test methods, protocols, reports, DCOs, etc.
    • Interfaces with suppliers, contract manufacturers, contract developers.
    • Ensures proper documentation of Design History Files per the companys procedures.

    Position Requirements

    • Prior experience in the medical device field
    • Proficient in use of MS Word, Excel, and PowerPoint
    • Ability to read and understand industry standards and regulations
    • Ability to perform basic statistics and willingness to learn more advanced statistical methods

    Education Requirements

    • Bachelors degree for engineering or comparable experience

    Experience Requirements

    • 2+ years quality engineering/assurance experience with medical devices
    • High level of organizational skills
    • Basic statistical skills

    Benefits

    • Health insurance
    • Dental insurance
    • Paid time off
    • Stock options
    • Bonus pay
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