Quality Manager

Lighteum Medical

Quality Manager leading Quality Operations and QMS for a medical device components company in San Diego. Ensure compliance and enhance product quality across the organization.

Posted 7/30/2026full-timeSan Diego • California • 🇺🇸 United StatesMid-LevelSenior💰 $125,000 - $140,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Quality Management Systems (QMS) and Quality Assurance within regulated manufacturing environments, with a strong focus on continuous improvement, compliance, and operational performance. Proven ability to lead teams, develop quality systems, and drive strategic initiatives to enhance product quality and customer satisfaction.

Highest-signal resume keywords

Quality Management System (QMS)Quality Assurance LeadershipContinuous Improvement InitiativesRegulatory ComplianceQuality Risk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Systems DevelopmentRoot Cause AnalysisNonconformance ManagementCAPA ProcessesManufacturing ProcessesInspection MethodsData AnalyticsPerformance MetricsQuality ControlQuality Assurance

Soft Skills

LeadershipCoachingTalent DevelopmentPerformance ManagementTeam Collaboration

Tools & Technologies

MS 365 ApplicationsERP SystemsMRP SystemsElectronic Quality Management Systems (eQMS)

Industry Keywords

Medical Device IndustryRegulated Manufacturing EnvironmentQuality ComplianceOperational PerformanceCustomer Satisfaction

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Lead Quality Operations and the Quality Management System (QMS) for the San Diego site.
Ensure compliance with regulatory, customer, and business requirements.
Provide strategic and operational leadership for Quality Assurance and Quality Control.
Drive continuous improvement and risk management initiatives.
Partner with site leadership to enhance product quality, operational performance, and customer satisfaction.
Responsible for the Quality Management System (QMS) and Quality Operations.
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.
Establish quality objectives and KPIs aligned with business goals.

Requirements

What you’ll need

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.
Minimum of 3 years of experience in a supervisory or management role.
Experience with quality risk management principles and methodologies within a regulated manufacturing environment.
Demonstrated success leading teams, driving change, and improving quality, compliance, and business performance through continuous improvement initiatives.
Demonstrated expertise in manufacturing processes, quality systems, inspection methods, root cause analysis, nonconformance management, and CAPA processes within a regulated manufacturing environment.
Proficient in MS 365 applications.
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.
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.

Benefits

Comp & perks

Comprehensive medical, dental, and vision insurance.
401(k) plan with generous company contribution and match.
Flexible spending accounts.
Life and disability insurance.
Generous paid time off policy, including PTO, sick leave, and paid holidays.