partnership with the Glaukos's external operations team, supply chain and Regulatory Affairs groups, and will be the interface internally with these teams as well as with the Quality groups at the CMOs/Distributors, as it relates to all quality assurance matters.
Ensures Glaukos products and procedures applicable to this scope are in compliance with all applicable worldwide product registration, distribution/economic operator, serialization, and quality system requirements. Participates with cross-functional teams to ensure manufacturing and distributing activities are properly completed on schedule ensuring compliance with ISO 13485, EU-MDR, and 21CFR 4, 210, 211, 820 and any other applicable
regulations. What will you do? General Quality Management Responsible for: ensuring that Glaukos quality system requirements are effectively established and maintained in accordance with quality system regulations and reporting to Sr.
Management on the performance of the quality system elements specific to manufacturing, post-market distributing activities. Activities include oversee CMO and world-wide distributors processes. Advises on areas of compliance risk and recommends appropriate corrective and preventive actions. Implements policies when selecting methods, techniques, and evaluation criteria for obtaining results. Works on issues where analysis of situations or data requires
an in-depth knowledge of organizational objectives. CMO Support Activities Oversee quality applicable aspects of components, drug substances, manufacturing, labeling and packaging, finished goods release and distribution performed by suppliers/vendors for all Glaukos products including medicals, medical devices, and combination products.
Sustain and optimize procedures for the oversight of all contracted and subcontracted services performed by a CMO for Glaukos. Ensure current and accurate Quality Agreements are in place and trained on by impacted Glaukos staff for CMOs. Drives, leads, and troubleshoots quality investigations at contract manufacturers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.
Serves as Glaukos Quality Person in Plant for CMO(s) Ensures contract manufacturers are compliance ready for regulatory inspections and monitor inspection progress during inspections. Post-Market Responsible for partnering with CMOs and Distributors to investigate product complaints in accordance with established procedures. Perform trend analysis on a routine basis and review for any patterns. Ensure prompt escalation and complete documentation for any high-risk complaint or trend.
Support Medical Safety with Vigilance, MDRs, and other regulatory reporting activities. Lead the Post - Production Risk backssment process. Assist with FDA and other compliance audits including corporate audits. Supplier/Distribution Quality Management Collaborate with Operations, Supply Chain, Business System Group and EHS functions on development & execution of distribution management strategy. Monitor distribution performance and distribution quality to ensure desired levels of performance and prompt escalation of identified trends/concerns. Creation of distributors economic training, on-boarding new distributors.
Established and maintained procedures for the oversight of distribution quality management activities associated with Glaukos products. Oversee distribution quality management activities for distributors. Oversight to include confirmation of compliance, management of quality audits, support necessary Regulation filings/reporting, inspection readiness activities, and appropriate resolution of corrective and preventive action plans, as required. Develops, implements, and manages a distribution management system appropriate for the activities of Glaukos.
Leadership Promotes within the organization the understanding of the Quality System Regulations and the benefits of achieving high standards of compliance. Ensure all behaviors are aligned with the positive Glaukos culture of product and process excellence, high integrity and demonstrated commitment to excellence in communication, collaboration, customer focus, and courage to do the right thing throughout the organization Develops, implements, and communicates the quality strategy, policies and programs How will you get here? Bachelor's Degree in a scientific, quality, or regulatory discipline with 8+ years industry experience; or 6+ years with a Master's Degree; or 4+ years with a Ph D.
Knowledge, Skills, and Abilities Current, in-depth knowledge of FDA, European Union and other international regulatory, quality and clinical requirements pertaining to medical devices and medicals used in ophthalmic surgery. Experience with internal and vendor auditing. Experience with facility, process, and product validations. Excellent analytical skills (interpret data, summarize data, present data). Excellent written and verbal communication skills with demonstrated success communicating with various health authorities around the world.
Motivated and able to work independently, as well as within a team. Exhibits personal integrity, credibility, and responsibility. Excellent organizational skills and ability to work on multiple projects/tasks. Meets milestones, budgets, and schedules. Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family. Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide.
And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class!
Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years! Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction including interactionual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
ABOUT US Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and medical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases. Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device-the i Stent®-in the United States, followed by our next-generation i Stent inject® device in September 2018 and i Stent inject® W in September 2020.
In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and medical therapies for glaucoma, corneal health, and retinal diseases. Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol " GKOS" Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employmentwithout regard to race, color, religion, interaction including interactionual orientation and genderidentity, national origin, disability, protected Veteran Status, or any othercharacteristic protected by applicable federal, state, or local law.
