Quality Engineer

PSC Biotech•Santa Ana, CA

17h•Hybrid

About The Position

PSC Biotech provides essential services to the life sciences industry, ensuring healthcare products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. The company operates globally with a multi-cultural team, focusing on client success and employee development, offering a compensation and benefits structure that rewards employees and provides tools for growth and learning. The role is for an experienced Quality Engineer who will provide hands-on support for GMP investigation activities related to calibration Out-of-Tolerance (OOT) events for process and utility instrumentation. This position will primarily focus on root cause investigations, documentation, and CAPA development, while also supporting broader quality engineering activities in alignment with FDA and GMP requirements.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
5–8 years of experience in Quality Engineering, with a strong focus on investigations and CAPA within a GMP-regulated environment.
Demonstrated experience leading or supporting calibration OOT investigations and root cause analysis.
Solid understanding of GMP regulations, FDA expectations, and quality systems.
Strong technical writing skills with the ability to document investigations and quality records clearly.
Ability to work independently, manage multiple priorities, and meet aggressive timelines.
Strong communication and collaboration skills, with experience working cross-functionally.
Ability to support onsite activities as required, particularly during initial project phases.
Must be authorized to work in the U.S

Nice To Haves

Experience working with regulated instrumentation and calibration-related documentation preferred.

Responsibilities

Lead and support investigations associated with calibration Out-of-Tolerance (OOT) events for GMP-critical instrumentation.
Perform root cause analysis and document investigations in accordance with established quality systems and regulatory expectations.
Develop, document, and support corrective and preventive actions (CAPA) resulting from OOT events and related deviations.
Assess product and process impact related to instrument performance and calibration events.
Coordinate closely with instrument owners, engineering, metrology, and quality stakeholders to obtain relevant data and drive timely investigation closure.
Support remediation of investigation backlogs and ensure adherence to site timelines and quality standards.
Review and ensure compliance of quality documentation, including deviations, investigations, and CAPAs.
Apply sound quality engineering judgment to ensure compliance with GMP, FDA, and applicable regulatory guidelines.
Contribute to continuous improvement initiatives related to investigation processes, documentation quality, and compliance practices.
Support other quality engineering activities as needed, including audits, trend analysis, and quality system improvements.