Quality Manager

QUALITY MANAGER

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 Med Tech 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.

We offer a comprehensive benefits package designed to support our associates' well-being. Our health and wellness benefits feature comprehensive medical, dental, and vision insurance. To promote financial security, we also provide a 401(k) plan with generous company contribution and match, flexible spending accounts, and life and disability insurance. Our paid time off policy is generous, including PTO, sick leave, and paid holidays.

The Quality Manager leads Quality Operations and the Quality Management System (QMS) for the San Diego site, ensuring compliance with regulatory, customer, and business requirements. This role provides strategic and operational leadership for Quality Assurance and Quality Control, drives continuous improvement and risk management initiatives, and partners with site leadership to enhance product quality, operational performance, and customer satisfaction

• Responsible for the Quality Management System (QMS) and Quality Operations, ensuring compliance with applicable regulatory, customer, and business requirements.
• Provide leadership, coaching, talent development, and performance management for Quality Assurance and Quality Control teams.
• Develop, implement, and maintain quality systems, procedures, controls, and metrics to ensure consistent product and process quality to meet customer expectations and quality standards.
• Establish quality objectives and KPIs aligned with business goals to drive compliance, operational excellence, and continuous improvement.
• Leads quality risk management for products, processes, suppliers, and quality systems across the product lifecycle.
• Ensures effective management of CAPA, nonconformances, deviations, complaints, adverse events, and change controls.
• Lead Management Reviews and provide executive leadership with updates on quality performance, compliance, risks, and improvement initiatives.
• Direct internal, supplier, customer, certification, and regulatory audit programs and ensure timely closure of findings and corrective actions.
• Ensures audit readiness and leads Quality representation during customer, certification, and regulatory inspections.
• Partner with cross-functional teams to integrate quality requirements throughout the product lifecycle and business processes.
• Establishes and maintains an effective supplier quality management program, including supplier qualification, monitoring, audits, performance reviews, and corrective actions.
• Promotes a prevention-based quality culture through employee training, risk management, process controls, data analysis, and continuous improvement initiatives.
• Provides leadership and direction to the Quality team through frontline supervision, ensuring effective execution of quality controls, compliance activities, and continuous improvement initiatives.
• Other duties as assigned.

The incumbent reports to the Quality Director and is responsible for the overall leadership and effectiveness of Quality Operations and the Quality Management System (QMS) for the San Diego site. The role works cross‑functionally with Operations, Production, Engineering, Customer Service, Sales, and other business functions to ensure quality requirements are integrated into manufacturing processes and business operations. The incumbent serves as a key business partner, driving quality performance, regulatory compliance, continuous improvement, and customer satisfaction initiatives.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The…