Posted on September 05, 2017
The position is responsible for assuring compliance to product requirements/specifications and applicable medical device state, federal, and international standards, regulations and laws, including QSRs, Medical Device Directives, ISO13485:2003, and other ISO/EN standards, and AAMI/ANSI standards.
- Develop, implement and maintain Quality Systems and associated procedures and processes in compliance with appropriate regulations and Optovue standards
- Develop and manage quality system metrics to ensure quality objectives are met and provide input to Management Review
- Coordinate Corrective Action and Preventive Action (CAPA) Process
- Facilitate continuous improvement working with process owners to identify root causes of nonconformities and determining appropriate process or product changes to prevent recurrence
- Assist with the management of the Internal Audit program and Inspection Readiness activities
- Coordinate Internal Audits and facilitate corrective actions on audit findings.
- Ability to generate risk analysis and failure mode effective analysis documents for company products and systems. Familiarity with ISO 14971
- Must be familiar with design control systems for medical devices including product launches
- Perform other activities, as required
- Education: B.S. degree in an engineering discipline or equivalent is required.
- Experience: at least 8 years medical device experience.
- CQE, RAC, RAB, or other quality and regulatory certificates preferred
- Computer literate and proficient in Microsoft Office Suite.
- Strong communication skills, verbal and written
- Demonstrated ability to deal with unresolved situations, frequent changes, delays or unexpected events
- Must be able to follow established policies and procedures, create and/or update procedures, and comply with regulatory requirements
- Ability to recognize problems, recommend and implement solutions.