Quality Software Engineer II Onsite San Clemente

Glaukos Corporation; San Clemente; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An innovative medical device company is seeking a Quality Software Engineer II to ensure that their software solutions meet the highest regulatory standards. In this role, you will develop and implement quality assurance programs for GxP systems, collaborate with cross-functional teams, and conduct thorough testing to ensure compliance. With a focus on continuous improvement, you will analyze quality metrics and participate in audits, all while staying updated on industry trends. This position offers an exciting opportunity to contribute to transformative healthcare solutions in a dynamic environment.

Formación

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

Responsabilidades

• Develop and maintain software quality assurance programs for GxP systems.
• Collaborate with teams to ensure software quality objectives are met.

Conocimientos

Software Quality Assurance

GxP Regulations

C++

Java

Python

Analytical Skills

Problem-Solving

Attention to Detail

Educación

Bachelor's degree in Computer Science

Relevant Certifications (CSQE)

Herramientas

Version Control Systems

Bug Tracking Systems

Automated Testing Tools

Descripción del empleo

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.

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