Essential Duties & Responsibilities
- Ensure plant conformance with validate processes and customer requirements and expectations.
- Train and assess the competency of personnel to effectively perform all required inspections to identify non confirming product.
- Train and assess competency of the proper review and approval of Device History Records by quality personnel.
- Audit inspections to ensure they continue to be performed in accordance with internal or customer driven requirements.
- Audit manufacturing processed to identify areas of improvement.
- Communicate, identify, and facilitate investigations into customer complaints issues.
- Facilitate communication between operations, engineering, quality and customer (where appropriate) to optimize continuous improvement and issue resolution results.
- Segregation, control and disposition of non-conforming product.
- Identify, recommend and perform quality training as needed.
- Ensure maintenance and control of production quality records.
- Audit root cause and corrective actions resulting from process control variances.
- Supports the appropriate team personnel in the investigation of root causes and corrective action of internal rejects, corrective/preventive action, out of control SPC points, and customer complaints.
- Identify needs for SPC and statistical studies and perform as necessary.
- Continually study the existing quality system and make recommendations for improvements.
- Perform improvements projects as identified.
- Facilitate site 3rd party audits and internal audits.
- Support in evaluation of customer specification and procedures.
- Manage all activities related to the MCI’s and QS’s.
Knowledge | Experience | Skills
- Knowledge in Microsoft Office tools
- Technical writing
- Understanding of injection molding process preferred
- 3+ Years supervisory experience
- Leadership skills
- Multi-task in fast-paced environment, manage multiple tasks and changing priorities using strong organization and prioritization skills
- Quickly understand concepts and think through possible solutions and implications
- Read and interpret quality and specification data with an understanding of company policies, procedures, and internal controls
- Effectively present information and respond to questions from groups of managers and colleagues
- Read, analyze and interpret documents such as drawings, blueprints, and production schedules
- Strong analytical and troubleshooting/problem solving skills with an emphasis on attention to detail balanced with a big picture focus and ability to work cooperatively with others. Collects and researches data, designs work flows, and procedures
- Computer Skills; spreadsheet, word processing, and electronic mail systems.
- Bilingual: English/Spanish preferred
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