The Quality Systems Specialist, II based in San Clemente, CA is responsible for ensuring our products meet the established standards of quality including reliability, usability and performance by focusing on enhancing and improving processes. Responsible for participating in the development, documentation, maintenance, and improvement of the Quality Management System; including quality processes, procedures and controls that monitor system performance and ensures conformance to the established standards necessary to maintain quality of products and sustainable customer satisfaction.

Responsibilities:

Quality System

* Interfacing with all departments to ensure the quality system is implemented and effective.

* Lead groups in improvement projects to ensure continued compliance of the quality system.

* Creating reports in Oracle Cloud and CATSWeb systems for CAPA Review Board, Management Review, CAPAs, and other trending requests.

* Maintaining existing modules within the Oracle Cloud and CATSWeb systems.

* Revising quality system procedures as needed.

Corrective and Preventative Actions (CAPA)

* Administrating the CAPA system in CATSWeb

* Tracking and trending CAPA phase due dates and interfacing with applicable departments to ensure timeliness of CAPA responses.

* Scheduling regular CAPA meetings to review the status of open CAPAs and associated metrics

* Supporting CAPA projects by leading or assisting individuals in root cause analysis, investigations, and corrective actions.

* Ensure CAPA files meet all regulatory and internal requirements

Audits

* Supporting internal audit system program.

* Participating in external audits as subject matter expert on quality systems.

* Supporting the management of backroom activities for external audits.

* Tracking any non-conformances, audit findings and opportunities for improvement through closure.

* Scheduling regular Audit meetings to review of status of open non-conformances.

* Provide monthly updates and metrics for the internal and external audit systems

Software

* Maintaining Approved Software List.

* Tracking and supporting software validation activities for quality related systems.

* Developing, reviewing and approving software validation processes.

Knowledge, Skills, and Abilities:

* Must have excellent documentation skills

* 3-8 years of industry experience

* Attention to detail and accuracy a must

* Medical device experience and working knowledge of QSR

* Medical device complaint experience preferred

* Experience working in a clean room and/or performing in-process assurance and manufacturing verification inspections desirable

* Team player, good written/oral communicator

* Able to thrive in a small, entrepreneurial environment

* Must be organized and able to coordinate activities with internal departments and outside vendors

* Must have excellent documentation skills

Education:

Bachelor's degree, preferably in a science or related field

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.