Quality Engineer (Medical Device)
NovaQual - Logan, UT

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NovaQual is seeking a Quality Engineer to provide quality engineering support and assistance to high-growth medical device companies in Utah. _This is an outstanding career opportunity for professional growth in the medical device industry.

Job Duties :

  • Specialize in areas of quality control engineering, such as design, incoming material,process control, product evaluation, system performance hardware performance, product reliability, inventory control, metrology, automated testing, software, research and development and administrative application
  • Ensure activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements
  • Develop, modify, apply, and maintain quality standards and evaluation methods for products and processes
  • May perform gap assessments and internal audits (Certified Quality Auditor Certification preferred).
  • Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality and compliance issues
  • Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership

Skills Required :

  • Knowledge and experience with applicable FDA regulatory requirements and Quality Management Systems for regulated medical device is required
  • Must be accurate, attentive to details, creative, innovative, and must understand and adhere to Standard Operating Procedures, QSRs (Quality System Regulations), FDA 21 CFR part 820 and other government regulations and have a thorough understanding of cGMPs for medical devices
  • ISO 13485:2003 knowledge and experience is desired but not required
  • Demonstrated knowledge of Quality Assurance methods, inspection, and document control.

Experience/Schooling or Degree Required :

  • Requires a minimum of 2 years of quality experience in the medical device industry.

NovaQual is a regulatory and quality consulting firm that serves ISO and FDA regulated industries. NovaQual is an Equal Opportunity Employer .


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