quality systems engineer

$61,880 - $77,480/Yr

Randstad - San Diego, CA

Full-time - Entry Level

San Diego, CA

Administrative and Support Services

About the position

The Quality Systems Engineer is responsible for developing and managing quality system controls within the SAP ERP system to ensure compliance in a regulated manufacturing environment, particularly in in-vitro diagnostics. This role involves leading quality management system (QMS) projects, collaborating with cross-functional teams, and providing expertise in quality assurance processes.

Responsibilities

• Develop and enhance global quality system controls in SAP, including controls for raw materials, components, and finished products.
• Lead QMS-related projects, from system transitions to integration, ensuring compliance with regulatory standards.
• Use project management best practices to achieve and exceed objectives, involving relevant stakeholders for technical feasibility.
• Communicate with quality stakeholders across sites to maintain alignment.
• Engage SMEs to validate all Quality department ERP requirements and coordinate design reviews for processes and configurations.
• Provide expertise on quality plans, risk assessments, and remediation.
• Apply systematic problem-solving methods to prioritize and resolve quality issues.

Requirements

• 0-2 years of experience in quality assurance within a regulated environment; in-vitro diagnostic manufacturing experience is a plus.
• Familiarity with standards such as 21 CFR 820, ISO 13485, and ISO 14971.
• Understanding of quality controls within an ERP (preferably SAP).
• Strong communication skills in communication, facilitation, and negotiation.
• Ability to thrive in a fast-paced, dynamic environment with changing demands.

Benefits

• Health insurance
• Incentive and recognition program
• 401K contribution