Senior Quality Engineer
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.
The Senior Quality Engineer,position will be based in San Clemente, CA and will directly support the full product life cycle of innovative ocular medical and pharmaceutical combination devices. This role includes the execution of equipment validations (IQ/PQ/OQ),writing protocols, reports, SOP’s. Supporting Quality system functions such as auditing, design control, risk management, supporting quality control analytical testing and manufacturing operations. This role will support the development of new product designs as well as the maintenance and enhancements of existing products.
· Execute equipment validations- writing validation protocols, executing IO/PQ/OQ validations,writing validation reports
· Maintaining Equipment
· Assist in the execution and implementation of method validations, USP, Compendial monograph (pharmacopeia) tests.
· Assist in the execution and implementation of method transfers.
Working with development teams to ensure:
· Clear and concise user requirements, product specifications, plans, verification and validation (V&V) studies, risk management strategies and other relevant design control deliverables.
· Test protocols that include qualified and repeatable test methods, appropriate risk-based sample sizes and clear test instructions that produce meaningful data.
· Robust reports which include appropriately analyzed test data to support regulatory submissions and product launches.
· Transfer plans that include complete DMR documents, quality control plans, training plans, approved suppliers and process validations.
· Complete and accurate design history files, both medical device and pharmaceutical.
· Maintain the risk management plans for all product lines ensuring compliance with ISO 14971.
· Leads Risk Management activities for effective product development and operational activities and ensure product safety and advocacy as a part of risk management activities.
· Ensure feedback loops are implemented and effective.
· Integrate risk management throughout the quality management system.
· Solid understanding of PFEMA, UFEMA, DFEMA
· Provide risk analysis leadership for all departments.
· Ensure all design control and risk management documents are maintained and meet regulatory requirements.
· Participate in and lead investigations for CAPA, manufacturing or quality system projects.
· Assess and improve quality system processes through data monitoring and trend analysis.
· May participate in internal and supplier audits, conducting audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
· Acts as an effective leader or team member in supporting quality disciplines,decisions, and practices.
· Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating,and resolving quality issues.
· Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
· Mentor for technical guidance for identifying and resolving quality issues.
· Quality on the floor, supporting quality control analytical testing, executing investigations etc.
· Auditing, supplier management.
Other Duties as Assigned:
· Additional other duties and projects as required to facilitate R&D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives.
· Other duties as assigned by management
· Prior engineering or production technician work experience.
· 7+ years of medical device/pharmaceutical experience at the Senior Engineer level or 12+ years of experience at the Principal Engineer level
· Work experience in a production or engineering environment
· Medical device experience required as well as pharmaceutical experience, ideal.
· Prior QC Chemistry experience, ideal.
· Working understanding of 21 CFR Part 820 and ISO 13845 and 14971 requirements
· GMP experience required
· Excellent written documentation skills with attention to detail and accuracy
· Must be self-motivated, goal-driven and results-oriented team player
· Must be organized and able to coordinate activities with internal departments
· Must be comfortable working in a clean-room environment
· Must have strong familiarity with AQL sampling plans and statistical attributes
· Bachelor’s Degree in Science/Chemistry or Engineering
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 accompany 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/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.