Quality Systems Engineer

About the role

At Lighteum, we pride ourselves on being more than just a place of work. We are a vibrant, innovative team committed to making a difference in the world of medical device components by enhancing the lives of patients worldwide by delivering innovative, high-quality medical components to the MedTech industry. Be a part of a team dedicated to playing a role in creating solutions that make a real impact. Your work will contribute to improving lives.

Principal Accountabilities

• Supports compliance with ISO 13485, customer, and internal requirements through effective implementation and maintenance of the QMS.
• Owns the NCMR process, including containment, investigation, disposition, corrective actions, and closure.
• Monitors and reports on nonconformances, investigations, corrective actions, and key QMS metrics; escalates significant quality and compliance risks as needed.
• Owns the CAR process, including investigation, root-cause analysis, corrective actions, effectiveness verification, and closure.
• Investigates product and process nonconformities using data-driven, risk-based methodologies.
• Disposes non-conforming material in accordance with procedures, customer requirements, and engineering judgment.
• Ensures quality investigations, NCMRs, CARs, containment, root-cause analyses, corrective actions, effectiveness checks, and supporting evidence are documented accurately, objectively, and in a timely manner in accordance with QMS procedures.
• Plans and conducts internal audits, supports corrective actions, and verifies effectiveness of implemented actions.
• Develops and maintains QMS metrics and quality trend reports, including NCMR and CAR aging, recurrence, closure performance, audit findings, and other indicators of QMS effectiveness; identifies adverse trends and escalates significant risks.
• Collaborates with Production, Engineering, and Quality teams to support containment, investigations, and resolution of quality issues.
• Supports process validation/qualification activities and evaluates quality data to determine whether validated processes remain effective and in control.
• Supports continuous improvement and risk reduction initiatives using Lean Six Sigma and structured problem-solving methodologies.

Scope

The Quality Systems Engineer reports to the Quality Manager and works cross-functionally with Operations, Engineering, Metrology, Document Control, and other functions to maintain and improve the Quality Management System (QMS). The role owns key quality system processes, including NCMRs, CARs/CAPAs, internal audits, and QMS metrics, while supporting quality investigations, corrective actions, and continuous improvement initiatives. Significant quality, compliance, and systemic risks are escalated to Quality leadership.

Qualifications

• Bachelor’s Degree in Engineering or related technical field, or equivalent Quality engineering experience with ASQ Certified Quality Engineer certification.
• Minimum of 3 years of experience in a manufacturing environment.
• Working knowledge of ISO 13485.
• Experience working with customers and cross-functional teams on manufacturing and process improvement initiatives.
• Ability to interpret engineering drawings, technical specifications, process documentation, and quality data.
• Experience managing or supporting CAR/CAPA processes, including root-cause analysis, corrective action, effectiveness verification, and closure.
• Experience with internal audits and follow-up of audit findings.
• Strong verbal and written communication skills.

Desirable

• Minimum 3 years’ experience with Value Stream mapping and Lean methodologies.
• Minimum 3 years of experience with developing and maintaining MSA, (x)FMEA, process flow diagrams, and Control Plans.
• Experience managing or supporting NCMR/nonconforming product processes, including containment, investigation, disposition, and closure.

Personal Skills and Key Competencies

• Building Collaborative Relationships: Identifying opportunities and taking action to build strategic relationships between one's areas, teams, departments, units, or organizations, including customers, to help achieve business goals.
• Continuous Improvement: Originating action to improve existing conditions and processes; identifying improvement opportunities, generating ideas, and implementing solutions.
• Adaptability: Maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
• Initiating Action: Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive.
• Planning and Organizing: Establishing courses of action for self and others to ensure that work is completed efficiently.
• Safety Awareness: Identifying and correcting conditions that affect employee safety; upholding safety standards.

Salary Range: $100,000 to $110,000 annually. Location: Onsite at the Company’s San Diego Facility.