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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 succeed.


The Experience

With a global presence and a diverse team, PSC Biotech is committed to uniting the best talent to create something exceptional. By joining our organization, you will find inspiration in your career, explore 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. You will receive not only a competitive compensation and benefits package but also the resources necessary for your growth and learning.


At PSC Biotech, we focus on more than just employment; we emphasize your career and future.


Your Role

The Software Validation Engineer will lead 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 comply with all design specifications and that V&V activities are conducted in accordance with applicable regulations and standards.


Key Responsibilities
  • Oversee the Software Verification and Validation (V&V) activities for embedded software in medical devices.
  • Design, implement, and execute software V&V test protocols and cases at various levels, including system, integration, and unit levels.
  • Develop necessary software testing tools for V&V.
  • Document software V&V reports and address any deviations.
  • Lead software risk management initiatives, including risk management plans, hazard identification, risk analysis, and mitigation controls.
  • Establish traceability between requirements, risk analyses, and test cases.
  • Review system and software requirements to ensure they are testable and complete.
  • Collaborate with key stakeholders 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 collaborate with vendors to develop and document testing strategies, scenarios, and protocols.
  • Ensure compliance of software V&V activities with regulations and intended use.
  • Communicate project updates and progress to management.
  • Perform additional projects and duties 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.
  • Proficient in testing software systems.
  • Experience with testing medical devices that incorporate embedded software.
  • Familiarity with MES and other manufacturing 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.
  • Ability to thrive in a fast-paced environment.
  • Capability 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 enable our company to fulfill its mission. We aim to promote a healthy work-life balance, allowing you to enjoy your work while having the time and resources to live a fulfilling life.

  • Medical, Dental, and Vision coverage, with PSC covering 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, 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 ensures compliance with all applicable federal, state, and local laws regarding employment discrimination. We prohibit discrimination against qualified individuals in all aspects of employment.