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Software Quality Assurance Engineer

2 months ago

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

PSC Biotech is dedicated to providing 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 achievements.


We take pride in the roles we have played in helping our clients reach their goals.


The Experience

With a global presence and a diverse team, PSC Biotech is committed to uniting the best talents to create something exceptional. By joining our organization, you will find inspiration 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 career and future are our priority.


Your Responsibilities

The Software Validation Engineer will spearhead and execute software verification and validation (V&V) activities to ensure that products consistently meet their intended specifications. This role involves ensuring that software systems align with all design specifications and that V&V activities comply with applicable regulations and standards.


Key Responsibilities
  • Lead software verification and validation (V&V) efforts for embedded software in medical devices.
  • Design, implement, and execute V&V test protocols and cases at various levels including system, integration, and unit levels.
  • Develop necessary software testing tools for V&V.
  • Document V&V reports and address any deviations.
  • Oversee software risk management activities, including planning, hazard identification, risk analysis, and reporting.
  • Establish traceability among requirements, risk analysis, and test cases.
  • Review system and software requirements to ensure they are testable and complete.
  • Collaborate with key stakeholders such as R&D, Manufacturing, Quality & Regulatory, and IT to enhance testing and validation strategies, improve productivity, maintain compliance, and meet project timelines.
  • Provide expertise in testing principles and methodologies to ensure robust testing and validation of technical solutions.
  • Guide team members and work with vendors to develop and document testing strategies, scenarios, and protocols.
  • Ensure compliance of V&V activities with 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.
  • Experience with the Software Development Life Cycle.
  • Proven experience in testing software systems.
  • Experience with medical devices that incorporate embedded software.
  • Familiarity with Manufacturing Execution Systems (MES) or similar applications.
  • Experience in software testing, quality assurance, and test protocol development.
  • Strong understanding of FDA regulations and guidance for software validation.
  • Knowledge of IEC 62304 and ISO 14971 standards for risk management.
  • Able to thrive in a fast-paced environment.
  • Ability to work independently with minimal supervision.
  • Excellent interpersonal and communication skills.
  • Availability to support Pacific or Central Standard Time working hours.

Benefits

PSC Biotech offers a comprehensive benefits package, emphasizing our commitment to investing in our employees who drive our mission and success. We promote a healthy work-life balance, ensuring you enjoy your work while having the time and resources to live 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. We comply with all applicable federal, state, and local laws regarding employment discrimination, prohibiting discrimination against qualified individuals in all aspects of employment.