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Quality Assurance Engineer

 

We are looking for a Quality Assurance Engineer to join our growing Quality Assurance and Regulatory Affairs team. They will plan, coordinate, and perform quality assurance activities designed to ensure quality production of multi-electrode arrays, data acquisition systems, and other technical interfaces.

Annual Salary Range $47,000-70,000 depending upon experience

The applicant must be willing to relocate to Salt Lake City, UT if not already local.

Requirements:

    —Bachelor’s degree in engineering, science, or equivalent education in quality related courses
    —Minimum 3 years combined experience in QA or Manufacturing in the medical device/pharmaceutical industry
    —Knowledge of FDA Quality System Regulation
    —Knowledge of ISO 9001/13485
    —Experience in establishing and maintaining quality system elements
    —Experience in auditing and FDA inspections
    —Must have good organizational skills and work independently with little supervision
    —Must have excellent reading, writing and communication skills in the English language
    —Must be proficient in computer skills using Microsoft Office

Job Duties:

    —Maintains quality assurance objectives
    —Performs quality assurance reviews of design documentation for compliance with stated requirements, including company quality records
    —Writes, reviews, approves company GMP-related policies and SOPs
    —Designs and implements quality assurance training programs
    —Manages the calibration process
    —Coordinates the CAPA, ECO and Nonconforming products meetings and reviews
    —Prepares quality metrics for management reviews
    —In conjunction with Engineering, determines inspection characteristics for incoming, in-process and finished components and products
    —Coordinates receiving inspection of components and contracted product
    —Participates in 3rd party audits
    —Performs quality assurance reviews of validation documents (protocols, technical reports, etc.)
    —Investigates customer complaints regarding quality
    —Creates product labeling
    —Maintains a working knowledge of government and industry quality assurance codes and standards
    —Updates and maintains FDA UDI database
    —Performs other assignments as required by the Management

To apply, send your resume and cover letter to jobs@blackrockmicro.com.

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