Supplier Quality Engineer

Talently; Tustin (CA); On-site; USD 80,000 - 105,000; Full time

Job summary

Talently is seeking a Supplier Quality Engineer for on-site work in Tustin, California. You will manage nonconforming materials and collaborate with suppliers to ensure product quality in a regulated manufacturing environment.

Responsibilities include leading root cause analysis, CAPA activities, and reporting metrics while ensuring compliance with QMS, GD&T, and Good Documentation Practices.

Qualifications

• Knowledge of MRB, nonconforming material processes, CAPA, and supplier corrective action activities.
• Understanding of QMS procedures, Good Documentation Practices, and regulated manufacturing requirements.
• Familiarity with ISO 13485, FDA QSR, ISO 9001, or comparable quality standards.

Responsibilities

• Maintain the nonconforming materials process and associated ERP activities.
• Process nonconformance events, evaluate impact, review history, and support disposition decisions.
• Participate in root cause analysis, CAPA, and supplier corrective action requests.

Skills

MRB

CAPA

GDP

QMS

ISO

Education

Bachelor's degree in engineering, science, quality technology, or related discipline

Tools

M2M ERP

Minitab

CMM

Job description

Location: On Site - Tustin, California, United States

Skills: MRB, CAPA, GDP, QMS, ISO

About the Medical Devices Company / The Opportunity:

Join an innovative company in the medical devices industry committed to delivering high-quality products within a highly regulated manufacturing environment. This opportunity allows a Supplier Quality Engineer to contribute to nonconforming material management, supplier collaboration, quality system compliance, and continuous improvement. Working on site in Tustin, California, you will partner with cross-functional teams to help ensure product quality, regulatory compliance, and reliable manufacturing outcomes.

Responsibilities:

• Maintain the nonconforming materials process, including associated ERP activities, records, and documentation.
• Process nonconformance events by evaluating impact, reviewing history, coordinating containment, and supporting disposition decisions.
• Participate in root cause analysis, problem resolution, CAPA, and supplier corrective action requests.
• Support Material Review Board reporting and collaborate with production, planning, engineering, and suppliers.
• Prepare process metrics, perform statistical analysis, and trend nonconformance and quality data for management reporting.
• Ensure quality activities comply with established QMS procedures, Good Documentation Practices, customer requirements, and applicable regulations.
• Support quality assurance and engineering activities, including validation plans, quality practices, product inspection, and risk management assignments.
• Coordinate with internal teams and external suppliers to resolve quality issues and achieve established performance indicators.

Must-Have Skills:

• Knowledge of MRB, nonconforming material processes, CAPA, and supplier corrective action activities.
• Understanding of QMS procedures, Good Documentation Practices, and regulated manufacturing requirements.
• Familiarity with ISO 13485, FDA Quality System Regulation, ISO 9001, or comparable quality standards.
• Ability to read blueprints and specifications, with practical knowledge of GD&T.
• Hands-on inspection experience using calipers, micrometers, gages, indicators, vision systems, CMM, or similar equipment.
• Working knowledge of basic statistics, statistical sampling plans, data collection, analysis, and quality trending.
• Proficiency with Microsoft Office, particularly Excel, and strong technical writing skills.
• Bachelor's degree in engineering, science, quality technology, or a related discipline, with 0-2 years of quality, engineering, or manufacturing experience.

Nice-to-Have Skills:

• Experience supporting electromechanical product manufacturing or new product development environments.
• Familiarity with ERP or manufacturing data systems such as M2M.
• Experience using Minitab for statistical analysis and quality reporting.
• Knowledge of risk management tools, including FMEA, hazard analysis, and fault tree analysis.
• ASQ Quality Engineer certification or a comparable industry certification.
• Experience coordinating directly with suppliers, customers, and cross-functional manufacturing teams.
• Familiarity with AS9100 or additional industry quality standards.