Sr. Quality Engineer
The Sr. Quality Engineer will be responsible for Quality Assurance, Quality Control and ISO 9001:2015 Quality Management Systems.
Responsibilities:
Implement and maintain IS0 9001:2015 Quality Management Systems.
Perform QMS Internal Audits and Lead External ISO 9001:2015 QMS Registration Audits.
Responsible for maintaining the Quality Manual and Policy.
Monitor, Track and Improve Quality Objective/ KPI.
Responsible for identifying Key QMS Processes and owners.
Perform Management Reviews in accordance with Inputs/Outputs of IS0 9001:2015 QMS.
Implement and Train Team Members on the ISO 9001:2015 QMS.
Responsible for Advanced Product Quality Planning of New Products and Product Changes.
Work with Design Team on the Design Reviews, Design Verification and Design Validation.
Work with Manufacturing / Equipment Team in developing DFM, DFA and/or DFX.
Work with Equipment team in developing the Equipment Selection, Verification and validation within the scope of quality.
Develop and maintain Documented information system.
Develop and maintain QMS SOP/Work Instructions.
Performing DOE in developing as a part process development and validation. Develop and maintain Quality Control Plans, PFMEA & Process Flow Charts. Responsible for performing Measurement System Analysis, Calibration and Measurement System Validation.
Assist in analyzing VOC and converting them to functional Requirements and Characteristics.
Work with Supplier and Customer Design Team in DFMEA & DVPR. Understand Critical to Quality Requirements and develop inspection Gages/Poke yokes.
Responsible for developing inspection methods.
Identify, develop, monitor, and improve Product Quality KPI.
Champion 8D problem solving meetings to develop corrective & Preventive Actions.
Responsible for assisting in Supplier Selection, Evaluation, and performance monitoring.
Onboard new suppliers in developing Quality and Capacity.
Perform statistical analysis using JMP including but not limited to Distribution, Regression, DOE, Gage RR, ANOVA, Control Charts and Capability Analysis. Initiate Six Sigma DMAIC Projects and improve the product Quality.
Responsible for monitoring and training Quality Team members. Responsible for various processes identified by QMS and Maintaining them.
Other duties and responsibilities as assigned by the Management team.
Qualifications & Certifications:
• Bachelor’s degree in engineering preferred
• Minimum of 5 years quality assurance and quality control experience.
• ISO 9001:2015 Lead Auditor Certification required.
• Significant problem-solving skills/experience (DMAIC and 8-D)
• Preferred ASQ Six Sigma Green Belt and CQE certifications
• Through knowledge of statistical techniques including Design of Experiments
(DOE) and quality systems.
• Understanding 3Q6S.
• Advanced computer skills including MS Office (Excel, PowerPoint, MS Project)
ERP.
• Knowledge of advanced quality tools including APQP, FMEA, etc.
• Strong presentation, facilitation, and interpersonal skills.
Job Type: Full-time
Experience: ISO 9001: 3 years (Required)
Preferred: Internal ISO 9001:2015 Lead Auditor Certification; Statistical Process Control Experience; Six Sigma/ Black Belt