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 with NCMR/nonconforming product processes, including containment, investigation, and closure.
Experience managing CAR/CAPA processes, including root-cause analysis and corrective actions.
Responsibilities
Maintain and improve the Quality Management System (QMS) in compliance with ISO 13485.
Own the Nonconforming Material Report (NCMR) process from investigation to closure.
Monitor and report key quality metrics, escalating compliance risks as needed.
Conduct root-cause analyses and develop corrective actions to address nonconformities.
Plan and execute internal audits and support corrective action verification.
Benefits
Onsite position at the company's San Diego Facility.
Opportunity for professional growth in quality engineering.
Collaboration with cross-functional teams to enhance product quality.
Engagement in continuous improvement and Lean Six Sigma initiatives.
Full 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
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/ 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.
