Monitor the entire production cycle and perform regular tests to identify potential malfunctions as early as possible
Determine quality metrics for all manufacturing procedures
Able to continuously improve company’s QMS (quality management system)
Owner of process validations (IQ, OQ, PQ) and machine qualifications
·Owner of DOE (Design of Experiments) and statistical analysis
Identify technical issues, getting to the root of problems, create and manage the creation of respective documents such as SCAR,
Owner of Corrective Actions and Risk Analysis processes
Owner of training and developing junior quality engineers
Thorough knowledge of ISO 9001: 2015 standards
Design, install, and evaluate quality assurance processes, production and process controls, and procedures complying with ISO 9001 standards.
Support new product introduction process.
Conduct training of QA concepts and tools.
Interact with customers and suppliers on quality related issues.
Work with suppliers to develop preventive actions to assure consistent product quality.
Perform statistical analysis (gauge R&R, capability analysis, SPC) using Minitab.
Facilitate problem solving and continuous improvement activities (Lean and Six Sigma).
Monitor and act on quality indicators (FPY, RTY, and OCAPS).
Develop and maintain process/product controls including process/equipment validations.
Verify internal, supplier, and customer corrective action implementation and effectiveness.
Perform internal and supplier quality audits.
Train on quality methods.
Select gauging technique/methods.
Support FMEAs and Control Plan development to minimize process risks.
Manages corrective action system and respond to customer complaints.
Manage 3rd party and customer audits and develop appropriate corrective actions.
Perform Measurement System Analysis to assure adequate inspection techniques are implemented.
Support supplier development for adequate controls and processes to assure product quality.
Must know 8D reports and SEMI S2, SEMI S8, or F8 47 certs
Audit supplier processes for adequate mistake proofing and process controls.
Train internal auditors and manage the internal audit program.
Provide support for Lean and Six Sigma manufacturing and continuous improvement initiatives, companywide.
Other duties, special assignments, or projects as needed and assigned.
Qualifications & Certifications:
Bachelor’s degree in Quality, IE, ME preferred
Minimum of 5 years quality assurance and quality control experience.
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.
Experience:
ISO 9001: 3 years (Required)
License/Certification:
Statistical Process Control (Required)
Six Sigma Green Belt (Required)
Work Location: One location
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Retirement plan
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Experience:
- ISO 9001: 3 years (Required)
- 8D Reports: 3 years (Required)
- in a Semi-Conductor/Manufacturing environment: 3 years (Required)
Work Location: In person
