Quality Systems Engineer

Medical Device Components LLC; San Diego (CA); On-site; USD 100,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid time off

Job summary

Lighteum Medical in San Diego, CA is seeking a Quality Systems Engineer to maintain and enhance the site's QMS under ISO 13485. This role focuses on NCMR, CAPA, internal audits, and quality metrics, working with Operations and Engineering across departments.

The ideal candidate will drive investigations, corrective actions, and continuous improvement using data-driven methods and Lean Six Sigma, ensuring product quality and regulatory compliance.

Qualifications

• Bachelor's degree in engineering or related field; CQE certification is a plus.
• Minimum 3 years manufacturing experience in a regulated environment.
• Working knowledge of ISO 13485 and quality systems fundamentals.
• Experience with NCMR/CAR/ CAPA processes and audits.
• Ability to read engineering drawings and quality documentation.
• Strong communication and cross-functional collaboration skills.
• Lean Six Sigma tools and problem-solving methodologies.

Responsibilities

• Maintain and improve the Quality Management System (QMS) per ISO 13485.
• Own nonconforming material (NCMR) and corrective actions (CAR/ CAPA).
• Plan and conduct internal quality audits and track corrective actions.
• Develop and monitor QMS metrics and trends.
• Collaborate with Operations, Engineering, and Quality to resolve issues.

Skills

3+ years manufacturing experience

ISO 13485 knowledge

NCMR/CAPA processes

Internal audits

Root cause analysis

Data-driven investigations

Cross-functional teamwork

Strong communication skills

Lean Six Sigma

Education

Bachelor's Degree in Engineering or related field

ASQ Certified Quality Engineer (CQE)

Job description

Quality Systems Engineer

Full Time

San Diego, CA, US

Salary Range: $100,000 To $110,000.00 Annually

Location: This is an onsite position based at the Company’s San Diego Facility

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.

Job Purpose

The Quality Systems Engineer is responsible for maintaining and improving the effectiveness of the site Quality Management System (QMS) in accordance with ISO 13485 and company standards. This role owns and improves key quality systems processes, including nonconforming material, corrective action (CAPA/CAR), internal audits, and quality metrics. Working cross-functionally with Operations, Engineering, and other departments, the position drives investigations, corrective actions, regulatory compliance, and continuous improvement initiatives to enhance product quality and QMS effectiveness.

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.

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

QUALIFICATIONS/ KNOWLEDGE/ EXPERIENCE (TECHNICAL/ PROFESSIONAL KNOWLEDGE & SKILLS COMPETENCY)

• Bachelor's Degree in Engineering or related technical field, or equivalent Quality engineering experience with ASQ Certified Quality Engineer certification. Essential
• Minimum of 3 years of experience in a manufacturing environment. Essential
• Working knowledge of ISO 13485. Essential
• Experience working with customers and cross-functional teams on manufacturing and process improvement initiatives. Desirable
• Minimum 3 years’ experience with Value Stream mapping and Lean methodologies. Desirable
• Minimum 3 years of experience with developing and maintaining MSA, (x)FMEA, process flow diagrams, and Control Plans. Desirable
• Experience managing or supporting NCMR/nonconforming product processes, including containment, investigation, disposition, and closure. Essential
• Experience managing or supporting CAR/CAPA processes, including root-cause analysis, corrective action, effectiveness verification, and closure. Essential
• Ability to interpret engineering drawings, technical specifications, process documentation, and quality data. Essential
• Experience with internal audits and follow-up of audit findings. Essential
• Strong verbal and written communication skills. Essential

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.

Lighteum Medical is an Equal Opportunity Employer and encourages applications from qualified candidates regardless of sex, race, disability, age, sexual orientation, marital status, religion, belief, or any status protected by federal, state, or local law. If you require a reasonable accommodation to apply or participate in the interview process, please contact [e-mail].