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 Micro
Vention®TERUMOhas to offer.

Position Overview

The Program Leader, Quality Compliance manages internal and third-party audit program. Perform gap assessment on new quality system regulations and communicate the gaps to impacted associates. Conducts and leads internal investigation of third-party audit findings. Prepares compliance status reports, trends findings, identifies and supports improvement initiatives. Typical job duties:
  1. Manages overall internal audit program, including preparing audit schedule, conducting audit (process, products, and quality system), preparing audit reports, and reviewing documents to address audit findings.
  2. Manages activities to support third-party audits.
  3. Keeps abreast with all applicable regulations, performs and / coordinates gap assessment of new quality system regulations, and prepares plan for implementing the new regulations as related to changes in Quality System.
  4. Collaborates with various functions to implement new regulations.
  5. Develops and performs quality compliance training.
  6. Conducts and directs investigation of quality compliance issues and assists in preparing corrective actions related to third party audit findings.
  7. Prepares quality compliance status report, trend findings, and escalates critical issues that warrant further actions.
  8. Creates and/or revises procedures to ensure compliance or drive improvement.
  9. Performs other duties and responsibilities as assigned
  • Qualifications
    1. Must have a Bachelor’s Degree or equivalent experience.
    2. Must have five or more years of quality compliance related experience in the medical device industry including combination products
    3. Must have a valid quality auditor certification by a recognized organization (i.e., ASQ Certified Quality Auditor, Exemplar Global-certified ISO13485 lead auditor training).
    4. Knowledgeable in 21CFR part820, 21CFR Part 4, ISO13485, ISO14971, MDD, CMDCAS, MDSAP.
    5. Successful experience working independently, effectively and confidently in a team environment.
    6. Ability to communicate effectively and partner with associates at various levels within the organization.
    7. Proficient with MS Word, Excel, PowerPoint, Visio and Outlook.
    Desired Qualifications
    1. Two or more years of supervisory experience
    2. Experience in MDSAP implementation
    3. Project Management certified
    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 atwww.microvention.com
    MicroVention® TERUMO as founded in 1997, employs approximately 1700 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.”