Descripción del Trabajo
This role works under limited supervision, partnering with Manufacturing, Quality and Quality Engineering to continuously improve the quality performance and ensure compliance with quality standards. Performs measurement and validation tasks to support Production and Quality requirements. Trains department personnel in the proper use and interpretation of quality plans, and reviews and analyzes daily quality performance to identify, contain, control, and improve quality.
***Shift is Monday through Friday, 8:00 AM – 4:30 PM.***
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Performs a variety of quality control test/inspections and complex analyses of raw materials, packaging materials and/or finished products from manufacturing to ensure quality standards and compliance to customer and regulatory requirements.
- Performs a variety of complex qualitative or quantitative tests on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance.
- Trains new inspectors regarding policies, procedures, inspection techniques. Monitors performance and institutes corrective action when necessary.
- Assures gauges are within the current calibration cycle and are effectively use and stored. Arranges for repair of gauges.
- Participates in design of experiments and process capability studies.
- Reviews Statistical Process Control (SPC) data. Maintains integrity of SPC data by correcting input errors, maintaining control limits, and creating new files, and retraining as needed.
- Analyzes data and writes summaries to validate or show deviations from existing standards.
- Recommends modifications to existing, or suggests new standards, methods, and procedures.
- Assists supervisor in prioritizing flow of work by coordinating the activities and daily work of employees of lower-level quality maintenance and quality technicians based on productions schedules.
- Prepare graphs or charts of data or enter data into computer for analysis.
- Performs product and process audits.
- Participates in mold qualification/validation process
- Conducts start-ups in accordance with inspection criteria.
- May inspect, measure, and test parts in accordance with blueprints, product plan requirements or engineering sketches.
- May plan, coordinate and perform layout inspection, process capability measurements and in-process inspection measurements.
- Responsible for recording bar code transaction using Worldwide Bar Code System.
- May oversee instrument calibration system, performs measurements and related calibration tasks.
- Ensures documentation and procedures are in compliance with customer specifications, industry standards and standard operating procedures.
- Works with all QA and Manufacturing personnel to achieve regulatory compliance.
- Maintain files for batch history records (BHR). Review BHR’s for completeness and accuracy. Fills out lot history closeout/Batch Release form. Work and follow up as needed with shipping to complete necessary information on Certificates of Compliance/analysis for product shipments.
- Maintains workflow, ensuring availability of proper materials.
- Maintains employee time and activity records
- Observes employees in assigned work area ensuring all housekeeping, health and safety regulations are followed.
- Comply and follow all procedures within the company security policy and company safety and quality programs.
- May perform other duties and responsibilities as assigned.
- General knowledge of blueprints, engineering specifications interpretation, inspection using measuring and test equipment, SPC software and measurement techniques, geometric dimensioning and tolerance and quality calibration processes required.
- General knowledge of process control charts, process capability studies and other statistical analysis applications.
- Ability to read and write English and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
EDUCATION & EXPERIENCE REQUIREMENTS
- Bachelor of Science required
- Experience with medical product and environmental testing