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Quality Engineer Hardware – Level II at Veran Medical
St. Louis, MO, US
  • Provides quality oversight/guidance for company medical devices, related to hardware (systems and instrumentation) and quality systems
  • Ability to combine input from multiple sources to provide solutions to organization regarding product quality, design and regulatory compliance
  • Reviews and approves work for inclusion in Medical Device Reports (MDRs) and provides support in the investigations of MDRs
  • Participates in complaint activities and corrective and preventive action (CAPA) related activities
  • Communicates significant issues or developments identified during quality assurance activities and provides recommended improvements
  • Provides Quality Engineering guidance to product development teams throughout the product development process to ensure compliance to the required deliverables, resulting in the development of safe and effective medical devices to include verification and validation activity
  • Analyzes data from various sources including but not limited to nonconformances, complaints, etc. to drive decision-making and effective corrective and preventative actions
  • Key participant in change management and provides guidance for new product development and existing products and processes
  • Recommends, leads and/or supports projects for improvements to the Quality System

 

Qualifications:

  • Bachelor’s degree preferred OR demonstrated equivalent experience
  • 3 to 5 years of relevant medical device industry experience, preferred in Quality Engineering
  • Certification as an ASQ Quality Engineer preferred, but not mandatory
  • Working knowledge of Quality concepts, regulatory compliance requirements and tools including ISO 13485:2016, FDA Quality System Regulation, EU MDR, etc. preferred
  • Applies organizational and technical knowledge to move teams through issues
  • Proficient in product & process development concepts, including change control, design verification and validation and risk management
  • Problem solving abilities for medical device and process improvements
  • Excellent written and verbal communication skills, including ability to communicate technical information
  • Good recordkeeping and attention to detail
  • Ability to read, write and speak English
  • Organizational skills, detail oriented, trustworthy