Quality Engineer I
The Quality Engineer ensures that production meets customer quality requirements by interacting regularly with Engineering, Manufacturing, and Quality personnel regarding quality issues, First Article Submissions, dimensional layout inspection activities, and GD&T applications.
Responsibilities :
- Ensures quality requirements are met by interacting with Production and Engineering, to provide a systematic approach for identification of customer requirements and resolution of current or potential quality issues.
- Accountable to assist and direct the day-to-day activities of the Quality Analysts.
- Coordinate and execute the Process Validations using IQ, OQ, PQ, PPAP, QAP, and TMV for customer submission and approval.
- Responsible for drafting Validation Protocols, Reports, and statistical analysis.
- Establish and provide training on inspection plans and GD&T training to Quality control personnel, as needed.
- Assist with supervision of Quality Analysts done by Metrologists and QC Inspectors for GD&T activities.
- Assist in NPI launches and sustaining activity of product lines post Validations.
- Interact with Engineering, Manufacturing, and Quality personnel regarding inspection methods.
- Provide input to Engineering and Quality personnel regarding acceptance criteria and specification requirements.
- Ensure information to the tool room regarding customer requirements or quality issues is thorough and accurate.
- Develop documentation and standards for new processes, procedures, and systems, as appropriate.
- Provide the QE Manager with weekly reports on ongoing Validation & sustaining activities.
Requirements :
Bachelor's Degree or Associate Degree in Engineering preferred5-8 years of quality engineering experience in the plastics manufacturing Medical Device industry is a plusExperience in statistical applications and data analysis is a mustExtensive knowledge of measurement systems, blueprints, and GD&T applicationsExperience in Technical writingCertified CQE, a plusSix Sigma Green belt certification, a plusExcellent verbal and written communication skills