Software Quality Assurance Engineer

2 weeks ago

Santa Ana, California, United States PSC Biotech Full time
Job Overview

PSC Biotech is dedicated to delivering vital services to the life sciences sector, ensuring that healthcare products are developed, manufactured, and distributed to the highest standards while adhering to all relevant regulatory requirements. Our mission is to elevate our clients' success, and you can contribute to our collective achievements. We employ a diverse team of skilled professionals across strategically located offices worldwide, including North America, Europe, Asia, and the Middle East.


We take pride in the roles we play in helping our clients succeed.


The Experience

With a global presence and a multi-cultural workforce, PSC Biotech is committed to uniting the best talents to create something exceptional. By choosing to be part of our organization, you will have the opportunity to be inspired in your career, pursue your professional interests, and collaborate with individuals who appreciate and cultivate your skills.


We believe in mentoring and developing the next generation of industry leaders. Therefore, you will receive not only a competitive compensation and benefits package but also the resources necessary for your growth and learning.


At PSC Biotech, your role transcends mere employment—it's about your career trajectory and future potential.


Your Responsibilities
  • Lead and execute software verification and validation (V&V) activities for embedded software in medical devices.
  • Design, implement, and conduct software V&V test protocols and cases at various levels including system, integration, and unit levels.
  • Develop necessary software testing tools for V&V processes.
  • Prepare software V&V reports and address any deviations identified.
  • Oversee software risk management activities, including risk management planning, hazard identification, risk analysis, and mitigation controls.
  • Establish traceability among requirements, risk analysis, and test cases.
  • Review system and software requirements to ensure they are testable and comprehensive.
  • Collaborate with key stakeholders such as R&D, Manufacturing, Quality & Regulatory, and IT to enhance testing and validation strategies, boost productivity, maintain compliance, and adhere to project timelines.
  • Provide expertise in testing principles and methodologies to ensure thorough testing and validation of technical solutions.
  • Guide team members and collaborate with vendors to develop and document testing strategies, scenarios, and protocols.
  • Ensure compliance of software V&V activities with applicable regulations and intended use.
  • Communicate project updates and progress to management.
  • Undertake additional projects and responsibilities as assigned.

Qualifications
  • Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, or a related field.
  • A minimum of 7 years of experience in Software Quality, testing, verification, and validation within FDA-regulated industries.
  • Experience in designing automated testing solutions.
  • Familiarity with C++ and Python programming languages.
  • Hands-on experience with software V&V methodologies, processes, and troubleshooting practices.
  • Experience with the Software Development Life Cycle.
  • Proven experience in testing software systems.
  • Experience with testing medical devices that incorporate embedded software.
  • Familiarity with Manufacturing Execution Systems (MES) and other manufacturing applications.
  • Experience in software testing, quality assurance, and test protocol development.
  • Strong understanding of FDA regulations and guidelines for software validation.
  • Familiarity with the IEC 62304 standard.
  • Knowledge of the ISO 14971 risk management standard.
  • Ability to thrive in a fast-paced environment.
  • Capacity to work independently with minimal supervision.
  • Strong interpersonal and communication skills.
  • Able to accommodate Pacific or Central Standard Time working hours.

Benefits

PSC Biotech offers a comprehensive benefits package, emphasizing our commitment to investing in our employees who enable our company to achieve its mission. We strive to promote a healthy work-life balance, ensuring you enjoy your work while having the time and resources to lead a fulfilling life.

  • Medical, Dental, and Vision coverage - PSC covers 100% of qualifying employee medical premiums and 50% for qualifying dependents.
  • Insurance options including Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability, and more.
  • 401(k) plan with matching contributions.
  • Paid Time Off (PTO), Sick Leave, and Paid Holidays.
  • Education Assistance programs.
  • Pet Insurance options.
  • Discounted Fitness Memberships.
  • Financial perks and discounts.

Equal Opportunity Employment Statement: PSC is committed to a policy of Equal Employment Opportunity for all employees, interns, and applicants. Our policy is to comply with all applicable federal, state, and local laws regarding employment discrimination. We prohibit discrimination against qualified individuals in all aspects of employment.

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