Senior Quality Engineer
Glaukosis 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 ofmicro-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 fullproduct lifecycle of innovative ocular medical and pharmaceutical combinationdevices. This role includes the execution of equipment validations (IQ/PQ/OQ),writing protocols, reports, SOP’s. Supporting Quality system functionssuch as auditing, design control, risk management, supporting quality controlanalytical testing and manufacturing operations. This role will supportthe development of new product designs as well as the maintenance andenhancements of existing products.
· Executeequipment validations- writing validation protocols, executing IO/PQ/OQ validations,writing validation reports
· Assistin the execution and implementation of method validations, USP, Compendialmonograph (pharmacopeia) tests.
· Assistin the execution and implementation of method transfers.
Working with development teams to ensure:
· Clearand concise user requirements, product specifications, plans, verification andvalidation (V&V) studies, risk management strategies and other relevantdesign control deliverables.
· Testprotocols that include qualified and repeatable test methods, appropriate risk-basedsample sizes and clear test instructions that produce meaningful data.
· Robustreports which include appropriately analyzed test data to support regulatorysubmissions and product launches.
· Transferplans that include complete DMR documents, quality control plans, trainingplans, approved suppliers and process validations.
· Completeand accurate design history files, both medical device and pharmaceutical.
· Maintainthe risk management plans for all product lines ensuring compliance with ISO14971.
· LeadsRisk Management activities for effective product development and operationalactivities and ensure product safety and advocacy as a part of risk managementactivities.
· Ensurefeedback loops are implemented and effective.
· Integraterisk management throughout the quality management system.
· Solidunderstanding of PFEMA, UFEMA, DFEMA
· Providerisk analysis leadership for all departments.
· Ensureall design control and risk management documents are maintained and meet regulatoryrequirements.
· Participatein and lead investigations for CAPA, manufacturing or quality system projects.
· Assessand improve quality system processes through data monitoring and trend analysis.
· Mayparticipate in internal and supplier audits, conducting audits, including closingout audit findings, creating audits finding reports and determine propercorrective and preventive actions.
· Actsas an effective leader or team member in supporting quality disciplines,decisions, and practices.
· Applysound, systematic problem-solving methodologies in identifying, prioritizing, communicating,and resolving quality issues.
· Assurein the development and execution of streamlined business systems whicheffectively identify and resolve quality issues.
· Mentorfor technical guidance for identifying and resolving quality issues.
· Qualityon the floor, supporting quality control analytical testing, executing investigationsetc.
· Auditing,supplier management.
Other Duties as Assigned:
· Additionalother duties and projects as required to facilitate R&D, Operations, Production,Engineering, Clinical and Regulatory goals and objectives.
· Otherduties as assigned by management
· Priorengineering or production technician work experience.
· 7+ years of medical device/pharmaceutical experience at the Senior Engineerlevel or 12+ years of experience at the Principal Engineer level
· Workexperience in a production or engineering environment
· Medicaldevice experience required as well as pharmaceutical experience, ideal.
· PriorQC Chemistry experience, ideal.
· Workingunderstanding of 21 CFR Part 820 and ISO 13845 and 14971 requirements
· GMPexperience required
· Excellentwritten documentation skills with attention to detail and accuracy
· Mustbe self-motivated, goal-driven and results-oriented team player
· Mustbe organized and able to coordinate activities with internal departments
· Mustbe comfortable working in a clean-room environment
· Musthave strong familiarity with AQL sampling plans and statistical attributes
· Bachelor’sDegree in Science/Chemistry or Engineering
We offer competitive salary (based onexperience),bonus eligibility, medical/dental/vision, lifeinsurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13company paid holidays, Employee Stock Purchase Program and 2 additional paiddays off to volunteer in our community, plus the opportunity to workfor accompany that is pioneering a new glaucoma treatment class. Check outour profile on The Muse to get an inside look at our companyculture: https://www.themuse.com/companies/glaukoscorporation
Glaukos has been recognized by the OrangeCounty Business Journal as one of the best companies to work for in inOrange County, check out page 8at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf
Glaukos Corporation is an EqualOpportunity/Affirmative Action Employer. Allqualified applicants will receive consideration for employment without regardto race, color, religion, sex including sexual orientation and gender identity,national origin, disability, protected Veteran Status, or any other characteristicprotected by applicable federal, state, or local law.