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    Quality Engineer - Minneapolis, United States - Medix

    Medix
    Medix Minneapolis, United States

    4 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    Summary Statement:

    Join our dynamic team and play a pivotal role in ensuring the compliance of our Quality Management System (QMS). We're seeking a dedicated individual to collaborate closely with our small team, ensuring adherence to regulatory standards and maintaining the highest quality standards on-site, full-time. This role is crucial in upholding the Quality System Manual procedures and ensuring strict compliance with its stipulations.

    Primary Responsibilities:

    Complaint Handling and Returned Goods Authorizations (RGAs):

    • Oversee complaint handling module, managing the entire process from entry to investigation, reporting, and trend analysis.
    • Input complaint data into post-market surveillance records and coordinate returned goods authorizations, liaising with sales and marketing.
    • Conduct evaluations of returned devices.

    Supplier Management:

    • Implement comprehensive supplier controls, including performance monitoring, credential reviews, and agreement establishment.
    • Develop risk-based sampling plans for receipt inspection procedures and manage supplier management system.
    • Conduct remote and on-site supplier audits, including planning and report generation.

    Document Coordination, Reviews, and Approvals:

    • Facilitate formal Document Change Reviews (DCRs) using the Grand Avenue Software (GAS) platform.
    • Initiate and review DCRs for various documents, including SOPs, manufacturing procedures, and technical documentation.
    • Assist with GAS platform administration and manage different modules within it.

    Corrective and Preventative Actions (CAPAs):

    • Investigate CAPAs, conduct root cause analyses, implement corrective/preventative actions, and verify their effectiveness.

    Gap Assessments:

    • Review relevant standards, regulations, and guidance documents to assess their impact on QMS and implement necessary changes.

    Non-Conforming Materials (NMRs):

    • Issue and approve NMR dispositions, including risk assessments and rework instructions. QMS Training Coordination:
    • Assist in coordinating training tasks, deliver training presentations, and oversee training quizzes.

    Secondary Responsibilities:

    • Perform receiving inspection activities, manage electronic production inventory systems, and assist with purchasing activities.
    • Maintain and manage quality records related to QMS and production activities.
    • Participate in risk management activities and audits, including notified body, FDA, and internal audits.
    • Support management review processes through data analysis and presentation preparation.
    • Provide assistance with production operations, order fulfillment, and field action activities.

    Qualifications:

    • Bachelor's degree in engineering or relevant discipline, or equivalent experience/certifications.
    • Experience in medical device industry with quality management systems.
    • Strong knowledge of medical device regulations, including EU MDR and US 21 CFR Part 820, as well as ISO
    • Experience with Grand Avenue Software (GAS) Electronic Quality Management System preferred but not required.
    • Ability to work independently and in a team environment, with excellent communication skills and proficiency in Microsoft Office applications.

    Join our team and contribute to the maintenance of our high-quality standards in the medical device industry

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