Quality Manager

Lighteum Medical; San Diego (CA); On-site; USD 125,000 - 140,000; Full time

Job summary

Lighteum Medical in San Diego is seeking a Quality Manager to lead Quality Operations and the Quality Management System at our San Diego site. You will drive compliance with regulatory and customer requirements, lead QA/QC teams, and advance continuous improvement initiatives to elevate product quality and customer satisfaction.

The role requires a Bachelor’s degree in a related field, 5–7 years in Engineering/Quality in medical devices, and 3+ years leading teams.

Qualifications

• Bachelor’s degree in engineering, Manufacturing, Quality, or a related field.
• 5–7 years of experience in Engineering and/or Quality, preferably in a medical device industry.
• 3+ years in a supervisory or management role.
• Experience with quality risk management principles within a regulated manufacturing environment.
• Proven ability to lead teams and drive quality, compliance, and business performance through continuous improvement.
• Expertise in manufacturing processes, quality systems, inspection methods, root cause analysis, CAPA in regulated settings.
• Proficient with MS 365 applications.
• Experience with ERP/MRP, eQMS, and data analytics/reporting tools to monitor quality and compliance.
• Able to work in both office and manufacturing environments, with occasional lifting up to 25 pounds.

Responsibilities

• Lead Quality Operations and the QMS for the San Diego site in compliance with regulatory and customer requirements.
• Provide leadership, coaching, and performance management for QA and QC teams.
• Develop and maintain quality systems, controls, and metrics to ensure product quality.
• Set quality objectives and KPIs aligned with business goals.
• Manage quality risk across products, processes, suppliers, and lifecycle.
• Oversee CAPA, nonconformances, deviations, complaints, and change controls.
• Lead management reviews and communicate quality performance to executives.
• Direct audits with internal, supplier, customer, and regulatory bodies; close findings.
• Ensure audit readiness during inspections and customer or regulatory reviews.
• Collaborate with cross-functional teams to embed quality throughout lifecycle.
• Maintain an effective supplier quality program with qualification, audits, and corrective actions.
• Foster a prevention-based quality culture via training and data-driven improvement.

Skills

Quality leadership

Regulatory compliance

Root cause analysis

CAPA

Risk management

Leadership

MS 365

ERP/MRP

eQMS

Data analytics

Manufacturing experience

Education

Bachelor’s degree in engineering, Manufacturing, Quality, or a related field

Tools

MS 365

ERP/MRP systems

eQMS

Data analytics tools

Job description

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.

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.

Be a part of our team today!

Salary Range: $125,000 to $140,000

Location: This is an onsite position based at the Company's San Diego facility.

QUALITY MANAGER

JOB PURPOSE

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

PRINCIPAL ACCOUNTABILITIES

• 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.

SCOPE

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.

PERSON SPECIFICATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. The physical requirements and work environment described are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

QUALIFICATIONS/ KNOWLEDGE/ EXPERIENCE

Bachelor’s degree in engineering, Manufacturing, Quality, or a related field.

Essential

5-7 years of experience in Engineering and/or Quality, preferably in a medical device industry.

Desirable

Minimum of 3 years of experience in a supervisory or management role.

Essential

Experience with quality risk management principles and methodologies within a regulated manufacturing environment.

Essential

Demonstrated success leading teams, driving change, and improving quality, compliance, and business performance through continuous improvement initiatives.

Desirable

Demonstrated expertise in manufacturing processes, quality systems, inspection methods, root cause analysis, nonconformance management, and CAPA processes within a regulated manufacturing environment.

Essential

Proficient in MS 365 applications.

Essential

Experience utilizing ERP/MRP systems, electronic Quality Management Systems (eQMS), and data analytics and reporting tools to monitor quality performance, compliance, and continuous improvement initiatives.

Essential

Ability to work effectively in both office and manufacturing environments, including prolonged periods of sitting, standing, walking, computer use, visual inspection activities, occasional lifting of up to 25 pounds.

Personal Skills and Key Competencies

Aligning Performance for Success: Focusing and guiding others in accomplishing work objectives.

Coaching and Developing Self and Others: Providing and welcoming feedback, instruction, and development guidance to help self and others excel in current or future job responsibilities; planning and supporting the development of individual skills and abilities.

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.

Driving Execution: Translating strategic priorities into operations reality; aligning communication, accountabilities, resource capabilities, internal processes, and ongoing measurement systems to ensure that strategic priorities yield measurable and sustainable results.

Leading Teams: Using appropriate methods and interpersonal styles to develop, motivate, and guide the