Engineer, Quality Systems

Job Title: Engineer, Quality Systems

• Engineer I, Quality Systems
• Engineer II, Quality Systems

Role Level: Individual Contributor

Supervisor/Manager Title: Director, Global Quality and Compliance

Job Location & Environment: Irvine, CA – Corporate Office

Job Description Summary: The Engineer, Quality is primarily responsible for supporting various elements of the Quality Systems such as, but not limited to, internal audits, external standards management, nonconformance, and CAPA management. In addition, support various QMS initiatives and processes including quality metrics, inspection readiness, management review, and continuous improvement.

Job Responsibilities:

• Collaborate with cross-functional teams such as Regulatory, Manufacturing Operations, and R&D to support the Quality Management System and core processes, eQMS system enhancements and validation activities, and ensure QMS requirements are embedded through product lifecycle.
• Promote proactive quality culture and support training on quality system fundamentals and practices across Quality and cross-functional groups.
• Lead gap assessments to support quality and compliance initiatives and compliance strategy
• Support evaluation of new and revised FDA guidance and international standards for applicability to commercial products.
• Partner with Regulatory Affairs and cross-functional teams in R&D and Operations to ensure requirements are correctly interpreted and implemented.
• Support or lead root cause analysis investigations for quality-related nonconformances and develop and aid in the implementation of effective corrective and/or preventive actions.
• Support FDA inspections, Notified Body audits, and internal audits, including investigation and timely closure of audit findings.
• Support technology innovation and digital transformation initiatives by evaluating and implementing modern analytical tools, automation, and advance quality monitoring systems.
• Support harmonization of quality KPIs across all sites globally

Required Education and Experience:

• Bachelor of Science degree in engineering or relevant scientific discipline required.
• Minimum of 2+ years of experience in the medical device, pharmaceutical industry, or life sciences technology is required. Level I, II, III DOE.
• Experience in Quality Systems, Regulatory Compliance, and/or Standards Management
• Direct experience in regulated manufacturing or R&D environment and knowledge of regulations and standards: 21 CFR Part 820, ISO 13485, ISO 14971.

Skills and Abilities Required for This Job:

• Must adhere to the company code of conduct and contribute to fostering a professional, collaborative, and respectful team working environment.
• Highly self-disciplined and proactively motivated.
• Must be able to work effectively and collaborate within cross functional teams.
• Must be able to effectively articulate quality issues, investigation results, and conclusions, both verbally and in writing, to technical and non-technical personnel.
• Must be able to take initiative and have the ability to perform hands-on work.
• Ability to manage multiple tasks with strong attention to detail.
• Proven risk management skills.

Physical Requirements:

• Minimal travel (~10%) may be required for audit support activities.
• Must be able to follow cleanroom, including compliance with applicable gowning and PPE requirements, and site safety protocols at all times.