Quality Systems Specialist
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.
As a Quality Systems Specialist based in our San Clemente, CA Headquarters, you will be responsible for ensuring our products meet the established standards of quality including reliability, usability and performance by focusing on enhancing and improving processes. The Quality Systems Specialist is also responsible for participating in the 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.
- Administration of the CAPA system
- Schedules regular CAPA meetings to review the status of open CAPAs & associated metrics
- Supports CAPA projects by leading or assisting individuals in root cause analysis, investigations, and/or corrective and preventive actions
- Ensures CAPA files meet all regulatory and internal requirements
- Maintains an annual internal audit schedule
- Leads or participates in internal audits
- Assists with preparations for external audits
- Tracks any internal/external audit non-conformances and opportunities for improvement through to closure
- Provides monthly updates and metrics for the internal and external audit systems
- Maintains the External Standards Master Index
- Administration of the external standards evaluation process by identifying potentially applicable standards and tracking the review/implementation process, as applicable.
- Conducts annual Quality System Regulations, Good Manufacturing, Good Documentation Practices training
- Revise's Quality System procedures as needed
Medical device or manufacturing quality engineering experience
Knowledge, Skills and Abilities:
- Must have excellent documentation skills
- Attention to detail and accuracy a must
- Medical device experience and working knowledge of QSR
- Pharmaceutical experience preferred
- Auditing experience and/or auditor certification preferred
- 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
Bachelor's degree, preferably in a science or related field
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture: https://www.themuse.com/companies/glaukoscorporation
Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf
Glaukos Corporation is an Equal Opportunity/E-Verify/Affirmative Action employer.
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