| || Program Leader, Quality Comp |
| || Program Leader, Quality Compliance |
| || 4613BR |
| || Aliso Viejo, California, USA |
| || 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.
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:
- 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.
- Manages activities to support third-party audits.
- 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.
- Collaborates with various functions to implement new regulations.
- Develops and performs quality compliance training.
- Conducts and directs investigation of quality compliance issues and assists in preparing corrective actions related to third party audit findings.
- Prepares quality compliance status report, trend findings, 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
| || Qualifications |
- Must have a Bachelor’s Degree or equivalent experience.
- Must have five or more years of quality compliance related experience in the medical device industry including combination products
- Must have a valid quality auditor certification by a recognized organization (i.e., ASQ Certified Quality Auditor, Exemplar Global-certified ISO13485 lead auditor training).
- Knowledgeable in 21CFR part820, 21CFR Part 4, ISO13485, ISO14971, MDD, CMDCAS, MDSAP.
- Successful experience working independently, effectively and confidently in a team environment.
- Ability to communicate effectively and partner with associates at various levels within the organization.
- Proficient with MS Word, Excel, PowerPoint, Visio and Outlook.
- Two or more years of supervisory experience
- Experience in MDSAP implementation
- Project Management certified
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.”
- 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