Glaukos

GLAUKOS – SR. QUALITY ENGINEER (SOFTWARE/R&D QUALITY) BURLINGTON, MA

How will you make an impact? 

The Senior Quality Engineer I, Software position will support the Quality Engineering (QE) staff for the full product lifecycle of innovative ocular medical device development; responsibilities include the execution of design control deliverables, risk management activities, Design History File compliance and supporting assessment/implementation of design changes to already approved medical devices. This role will support the development of new product software designs as well as the maintenance and enhancements of existing products from the software perspective.

What will you do?

Under general managerial supervision/oversight, works with development teams in the following areas:

Design Control and Risk Management 

• Work with application developers and product teams to support the development of medical devices with software.
• Support the development and qualification of software development tools and services 
• Assist in the review of the software test cases and test runs in support of design verification / validation activities
• Review Software Design Documentation
• Support in risk management activities for effective product development and operational activities ensuring compliance with ISO 14971, IEC 62304, ANSI/AAMI SW96.
• Support changes to product designs. 

Quality System 

• Assist in engineering change order preparation/review 
• Assist in quality system procedures periodic review 
• Assist QE CAPA owners on CAPA task follow up. 
• Assess and improve quality system processes through data monitoring and trend analysis. 
• May participate in internal audits, conducting audits. 

Other Duties as Assigned

Additional other duties and projects as required to facilitate R&D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives.

How will you get here?

• Bachelor's degree required. 
• 5+ years of medical device or experience in a semi-regulated industry is required, 8+ years preferred 
• Strong knowledge of medical device manufacturing and software development
• In-depth knowledge of GMP, ISO 13845, ISO 14971, EU MDD/MDR, GDPR – General Data Protection Regulation, and 21 CFR Part 820 FDA requirements, ISO 62304 and IEC 60601 software requirements.
• Expertise in medical product quality assurance (including the requirements for test protocols and statistical techniques). 
• Proficiency in various programming languages, such as C++, Java, or Python, and experience with software development tools, such as version control systems, bug tracking systems, and automated testing tools.
• Excellent documentation skills, attention to detail and accuracy 
• Team player, good written/oral communicator 
• Must be organized and able to coordinate activities with internal departments and outside vendors 
• Establishes reputation as an emerging leader internally with sustained performance and accomplishments
• Demonstrates strategic thinking and commercial/industry understanding in functional projects
• Proficient data entry and typing skills 
• ERP systems experience required 

#GKOSUS

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. 

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases. 

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients. 

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra “We’ll Go First,” which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. 

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 in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

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.