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 medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We’re a high-growth, customer-focused company 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.
Senior Quality Systems Specialist
Position Overview
This position will be responsible for maintaining and improving quality systems to ensure compliance with global regulatory requirements and ensuring that the quality systems are used effectively to support company quality policy and objectives. Establishes, prepares and analyzes reports/metrics/dashboard, supports the implementation of automated systems, supports the preliminary investigation on quality systems related issues, updates procedures and participates/facilitates Quality Systems related discussion. Drives activities related to Quality System improvements.
  • Establishes, collects and publishes quality system metrics/reports/dashboards.
  • Analyzes metrics and trends to drive improvement on overall Quality System program.
  • Facilitates quality system metric meetings and discussions among various team.
  • Leads and supports improvement efforts as part of departmental and cross functional quality improvement projects, including implementation of new QMS regulations.
  • Serves as implementation coordinator for new and enhanced quality metrics systems.
  • Prepares protocols, reports, and/or necessary documentation.
  • Executes and supports QMS system validation related activities.
  • Creates and revises procedures to ensure compliance or drive improvement.
  • Develops and conducts quality related training.
  • Supports auditing related activities (internal/external) ensuring the quality system is implemented and followed and maintains adherence to all quality procedures and processes.
  • Supports quality systems related investigation, corrective actions and effectiveness checks.
  • Performs other duties and responsibilities as assigned
  • Required Qualifications
    1. Bachelor’s Degree required or equivalent experience.
    2. Minimum five (5) years of quality assurance/compliance related experience in the FDA regulated industry.
    3. Working knowledgeable in 21CFR Part 820, 21 CFR Part 11, ISO13485 regulations.
    4. Successful experience working independently, effectively and confidently in a team environment.
    5. Ability to communicate effectively and partner with associates at various levels within the organization.
    6. Strong analytical skills and attention to details.
    7. Proficient with MS Word, Excel, PowerPoint, Visio and Outlook.
    Desired Qualifications
    1. Strong interpersonal skills, team player with good problem-solving ability.
    2. Good verbal and written communication skills.
    3. Ability to handle multiple projects concurrently.
    4. Knowledge of FDA Regulations and Application of Good Manufacturing Practices.
    5. Lean Six Sigma, Quality, and/or Project Management related certification, preferred.
    Additional Information
    • The primary work location for this position is Aliso Viejo, CA (company headquarters)
    • Candidates must be eligible to work in the U.S. and not require visa sponsorship.

    Comments
    MicroVention® TERUMO was founded in 1997, employs approximately 2,800 worldwide, and has experienced double-digit revenue growth year-over-year 3 years running. Recognized as one of the “Top Workplaces” in Orange County, California, 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”.