Quality Engineer

Irvine, United States | Posted on 02/12/2026

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

We are hiring Quality Engineers of varying experience levels to join our team! Quality Engineers play a critical role in ensuring products, processes, and systems meet internal quality standards and applicable regulatory requirements within a regulated biotechnology environment. This role is responsible for developing and maintaining robust quality systems, monitoring manufacturing and operational processes, and driving continuous improvement initiatives. Quality Engineers partner cross-functionally with Manufacturing, Engineering, and Quality teams to identify risks, investigate issues, and implement effective corrective and preventive actions that ensure consistent product quality and compliance.

• Monitor manufacturing and operational performance to proactively identify quality risks and improvement opportunities.
• Lead and participate in root cause investigations related to manufacturing failures, non-conformances, deviations, and customer complaints.
• Develop, implement, and track corrective and preventive actions (CAPAs) to ensure issues are effectively resolved and recurrence is prevented.
• Document investigation outcomes and ensure timely closure in accordance with quality system requirements.
• Design, implement, and maintain quality control systems, inspection criteria, and Standard Operating Procedures (SOPs) in alignment with regulatory and internal quality requirements.
• Support the development and continuous improvement of Quality Management System (QMS) elements, including deviations, CAPA, change control, and documentation practices.
• Ensure quality processes are audit-ready and support internal and external inspections as needed.
• Utilize Statistical Process Control (SPC) and other quality tools to analyze process data, identify trends and variations, and assess process capability.
• Collaborate with cross-functional teams to implement process improvements that enhance efficiency, reduce defects, and improve overall product quality.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• Experience working in a regulated biotech, pharmaceutical, or life sciences environment.
• Strong understanding of quality systems, GxP principles, and regulatory expectations (e.g., FDA, ISO, cGMP).
• Hands‑on experience with root cause analysis methodologies and CAPA management.
• Working knowledge of Statistical Process Control (SPC) and data‑driven process improvement tools.
• Strong technical writing skills with experience developing SOPs and quality documentation.
• Excellent analytical, problem‑solving, and cross‑functional communication skills.
• Ability to work independently while effectively collaborating in a fast‑paced, team‑oriented environment.
• Must be authorized to work in the U.S.
• No C2C at this…