Quality Software Engineer II Onsite San Clemente

Glaukos Corporation; San Clemente (CA); On-site; USD 80,000 - 130,000; Full time

Job summary

An established industry player in medical technology is seeking a Quality Software Engineer II to ensure compliance and quality in software solutions for GxP systems. This role involves developing and maintaining quality assurance programs, collaborating with various teams, and conducting audits to uphold the highest standards in software quality. If you are passionate about making a significant impact in healthcare through innovative technologies and possess strong analytical and communication skills, this opportunity is perfect for you. Join a forward-thinking company committed to transforming lives through groundbreaking products.

Qualifications

• 2-5 years of experience in software quality assurance, preferably in medical devices.
• In-depth knowledge of GxP regulations and quality management systems.

Responsibilities

• Develop and maintain the software quality assurance program for GxP systems.
• Collaborate with cross-functional teams to meet quality objectives.
• Conduct root cause analysis of software defects and implement corrective actions.

Skills

Software Quality Assurance

GxP Systems

C++

Java

Python

Root Cause Analysis

Analytical Skills

Communication Skills

Education

Bachelor's degree in Computer Science

Tools

Version Control Systems

Automated Testing Tools

Bug Tracking Systems

Job description

Quality Software Engineer II Onsite San Clemente

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Quality Software Engineer II Onsite San Clemente

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GLAUKOS – QUALITY SOFTWARE ENGINEER II (San Clemente, CA)

How will you make an impact?

Glaukos is a leading medical device and pharmaceutical company, committed to transforming healthcare through groundbreaking products and services. We are seeking a highly skilled Quality Software Engineer II, specialized in GxP systems, to join our team and ensure that our software solutions for medical devices and pharmaceutical products adhere to the highest quality and regulatory standards.

Job Description

GLAUKOS – QUALITY SOFTWARE ENGINEER II (San Clemente, CA)

How will you make an impact?

Glaukos is a leading medical device and pharmaceutical company, committed to transforming healthcare through groundbreaking products and services. We are seeking a highly skilled Quality Software Engineer II, specialized in GxP systems, to join our team and ensure that our software solutions for medical devices and pharmaceutical products adhere to the highest quality and regulatory standards.

What will you do?

• Develop, implement, and maintain the software quality assurance program for GxP systems in medical device and pharmaceutical products, in accordance with industry standards, regulatory requirements, and company guidelines.
• Collaborate with cross-functional teams, including software development, project management, and regulatory affairs, to ensure quality objectives are met throughout the software development lifecycle.
• Review and approve software documentation for GxP systems, including requirements, design specifications, test plans, and test results, to ensure compliance with applicable regulations and standards.
• Design, execute, and analyze test cases to verify that the GxP systems meet defined requirements and identify defects or deviations from expected performance.
• Conduct root cause analysis of software defects in GxP systems and collaborate with the development team to implement corrective and preventive actions.
• Monitor, analyze, and report on GxP system software quality metrics, such as defect density, test coverage, and pass/fail rates, to identify trends and areas for improvement.
• Participate in internal and external software quality audits, as well as regulatory inspections, as needed.
• Support continuous improvement initiatives by identifying opportunities to enhance GxP system software quality processes and methodologies.
• Provide guidance and training to team members on GxP system software quality assurance best practices and regulatory requirements.
• Stay informed on industry trends, new technologies, and regulatory changes to ensure continued compliance and competitiveness in the medical device and pharmaceutical market.
  
  
  

How will you get here?

• Bachelor's degree in Computer Science, Engineering, or a related field.
• A minimum of 2-5 years of experience in software quality assurance, preferably in the medical device or pharmaceutical industry, with a focus on GxP systems.
• In-depth knowledge of GxP regulations, software development processes, software testing methodologies, and quality management systems (e.g., ISO 13485, ISO 14971, IEC 62304).
• Familiarity with FDA and other international regulatory requirements for medical device and pharmaceutical GxP system software (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5).
• 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.
• Strong analytical, problem-solving, and decision-making skills, with the ability to identify root causes and implement effective corrective actions.
• Excellent communication and interpersonal skills, with the ability to work effectively both independently and in a team environment.
• Strong attention to detail and a commitment to delivering high-quality GxP system software solutions.
• Certified Software Quality Engineer (CSQE) or other relevant certifications are a plus.
  
  
  

#GKOSUS

About Us

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Medical Equipment Manufacturing

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