Quality Systems Engineer
Job Location:
San Diego, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Be a part of our team today!
Quality Systems Engineer
Full Time
San Diego CA US
Salary Range: $100000 To $110000.00 Annually
Location: This is an onsite position based at the Companys 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.
- 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.
QUALIFICATIONS/ KNOWLEDGE/ EXPERIENCE (TECHNICAL/ PROFESSIONAL KNOWLEDGE & SKILLS COMPETENCY) | |
Bachelors 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 ones 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
Required Experience:
IC
