The Quality Engineer (Systems) is responsible for ensuring that quality management systems and related processes comply with internal standards, customer requirements, and applicable regulations. This role focuses on maintaining, monitoring, and continuously improving quality systems, including documentation control, change management, risk management, and corrective and preventive action processes. The Systems Quality Engineer works closely with cross-functional teams to support audits, ensure data integrity, drive system effectiveness, and promote a culture of continuous improvement across the organization.
Job Responsibilities:
- Ensure compliance with applicable industry regulations (e.g., ISO, R2V3, etc) across all quality management systems (QMS).
- Lead internal and external quality system audits; coordinate audit schedules, prepare documentation, and drive corrective actions.
- Monitor and evaluate compliance risks; proactively identify gaps and implement effective mitigation strategies.
- Maintain and control quality records in accordance with document retention and regulatory requirements.
- Lead or support CAPA (Corrective and Preventive Actions).
- Ensure timely reporting and closure of quality events, deviations, and audit findings.
- Collaborate with product development, operations, and legal teams to ensure products and processes comply with global regulatory requirements.
- Participate in regulatory inspections and customer audits as the quality systems representative.
- Maintain up-to-date knowledge of applicable regulations, standards, and industry trends to ensure ongoing compliance.
Who You Are:
- Bachelor’s degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or a related field.
- 2+ years of experience in process quality engineering within a manufacturing environment.
- Must be bilingual in English and Spanish
- Must have a valid U.S. visa and be able to travel to the United States as needed for training, meetings, or business-related purposes.
- Strong knowledge of quality tools and methodologies (FMEA, SPC, MSA).
- Experience with ISO 9001(preferred).
- Proficiency in root cause analysis and problem-solving tools (8D, 5 Why’s, Ishikawa).
- Familiarity with Lean Manufacturing, Six Sigma, and continuous improvement techniques.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint).
We Are Seeking People Who:
- Act like owners.
- Are continually raising the bar.
- Are sincerely open-minded and willing to examine their strongest convictions with humility.
- Nurture and embrace differing perspectives to make better decisions.
What's in it for You:
- Competitive salary.
- Opportunities for professional growth and development.
- A supportive and collaborative work environment.
- Comprehensive benefits package.
We are an Equal Opportunity Employer. All qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin will be considered. No qualified applicants will be discriminated against on the basis of disability or protected veteran status.
