Quality Engineer for Alltrista Plastics (formerly Jarden Plastics/Newell)
This position reports to the Director of Design and Engineering and has three key areas of responsibility: 1) Work with Business Development, Sales and Engineering at the design and quoting process to insure quality requirements are defined and meet both the internal and external customer expectations. 2) Assist Customer and Plants with creation and execution of new product protocols, validation and reports. 3) Implement and maintain a strong Division Office Quality System.
1. Interfaces with customers along with Site Quality Managers to understand and communicate product and inspection requirements for new and customer supplied mold projects.
2. Develops and executes procedures for product and equipment Process Validations, such as IQ, OQ, PQ (Installation Qualification, Operational Qualification, Performance Qualification) of new and customer supplied molds and automation equipment
3. Coordinates, develops, and writes product and custom equipment inspection and calibration plans for new and customer supplied molds.
4. Help establish and implement strong quality systems, internal auditing, supplier approval, tooling PM, facility PM program, calibration, training and CAPA program.
5. Evaluates product from DOE activities to prepare for and support parametric release and quality assurance.
6. Performs and documents First Article/Protocol inspections for new, customer-supplied and modified molds.
7. Works with Site Quality Managers to develop predictive quality processes, including using SPC software to collect and evaluate process data for continual improvement.
8. Conducts routine audits/evaluations/analysis of manufacturing, engineering, tooling and warehousing activities to assess compliance with FDA or other customer specific regulatory compliance.
9. Continually updates knowledge of current state-of-the-art inspection/testing instrumentation and techniques and integrates into existing methods and programs.
·Bachelor’s Degree in engineering or related field.
·Overall, five to seven years’ experience in quality discipline in a medical or CPG high volume molding and assembly environment, with three to five years- in process/final/raw materials inspection.
·Three to five years-experience in SPC, sampling/auditing/reading blue prints/dimensioning and tolerance.
·Practical and direct experience utilizing continual improvement and quality tools to include control charts, capability studies, DOE, regression analysis, histograms and fishbone charts.
·Practical and direct experience with computer hardware and software including LAN/CIM, and statistical, graphical spreadsheets and word processing software.
·Background in corrective action and root cause analysis, preventative action and continual improvement.
·Knowledge of ISO 9001 based Quality Management Systems (QMS).
·Knowledge of ISO 13485 Medical Device with strong knowledge of Quality System implementation.
·Sitting at workstation approximately 85% of work time. Standing and walking approximately 15% of work time.
·Must be able to travel 25-50% of work time.
·Ability to work overtime or occasionally on weekends with short notice.
·Typical office environment with shelves overhead and above work surfaces.
Job Type: Full-time
- quality assurance: 5 years (Preferred)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off