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Supplier Quality Engineer
2 months ago
Top 3 required technical skills:
- Project & time management/organization/planning
- Minitab/data analysis
- problem solving
Nice to have skills:
- Inspection development
- Risk management
- Solidworks/Creo
- Six sigma
Job Description: The Engineer will apply knowledge of quality engineering principals and methods to ensure compliance with regulatory requirements and clients systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Job Responsibilities:
- Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
- Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
- Participate in design and drawing reviews to ensure that components meet requirements for design and patient safety requirements.
- Develop, validate, and improve component inspection strategies and methods to ensure parts meet drawing requirements.
- Responsible for defining supplier qualification requirements for components and custom materials, including supplier validations, clients receiving inspection test methods and fixture design.
- Develop, update, and maintain technical content of part qualification plans and reports.
- Investigate complex manufacturing product quality and compliance issues (e.g., NCR, CAPA, SCAR) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations, implement corrective actions, and document reports.
- Perform other duties and responsibilities as assigned.
Skills:
- Effective problem-solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc.)
- Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR’s and SCAR’s
- Ability to make sketches, engineering drawings and common computations.
- Ability to read and interpret technical drawing, schematics and computer-generated reports.
- Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).
- Understanding of Risk Management principles
- Previous experience with Keyence routine programming
- Six Sigma Green or Black Belt/LEAN Manufacturing experience a plus
- Ability to manage competing priorities in a fast-paced environment
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Education/Experience:
- Bachelor's degree (Engineering or Science) is required with 4 years of experience required or Master’s Degree (Engineering or Science) and 3 years of related experience required
