Position Overview

INNOVATION STARTS WITH YOU

Are you interested in working for an organization that is making a difference in people’s lives every day? We’re a high-growth company, customer-focused with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what MicroVention® TERUMO has to offer.

Position Overview

The Quality Systems Analyst performs preliminary assessment on CAPA/QAR/ audit findings, prepares and analyzes reports/metrics, updates procedures and participates/ facilitates Quality Systems related discussion. Drives activities related to audits and CAPA/QAR projects. Typical job duties:
  • Investigates issues related to audit findings, CAPA and QAR by collaborating with various functions (e.g., R&D, Production, Field Assurance, etc.)
  • Creates and implements metrics, and analyzes trends to drive CAPA/QAR and audit performance
  • Evaluates and analyzes the efforts in organizing, documenting and making recommendation to management on quality improvement process
  • Drives audit related activities including ensuring initial compliance, on-going preparation and monitoring of conformance to current processes
  • Identifies and escalates critical issues that warrant further actions
  • Creates and/or revises procedures to ensure compliance or drive improvement
  • Performs other duties and responsibilities as assigned
    1. Must have a Bachelor’s/Associate’s Degree or equivalent experience
    2. Must have three (3) or more years of experience
    3. Knowledgeable in 21CFR part820, ISO13485, MDD and CMDCAS regulations
    4. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations and Application of Good Manufacturing Practices
    5. Strong interpersonal skills, team player with good problem solving ability, and good verbal and written communication skills
    6. Strong analytical and attention to details
    7. Successful experience working independently, effectively and confidently in a team environment
    8. Ability to communicate effectively and partner with associates at various levels within the organization
    9. Proficient with MS Word, Excel, PowerPoint, Visio and Outlook
    Desired Qualifications
    1. Bachelor’s degree in Science and/or Engineering
    2. ASQ Certified Quality Auditor
    Additional Information
    • The primary work location for this position is Aliso Viejo, CA.
    • Candidates must be eligible to work in the U.S. and not require visa sponsorship.
    • For more information, visit our web site at www.microvention.com
    MicroVention® TERUMO as founded in 1997, employs approximately 2300 worldwide, and had 20% revenue growth in 2015. Recognized as one of the “Top Workplaces” in Orange County, California two years in a row, and we have a thriving culture that is innovative, customer-focused, clinically driven, demonstrates a team spirit, and empowers its employees to challenge the status quo. “MicroVention® TERUMO. Innovation Starts with You.”