Analysis Skills, Auditing, Blueprints, Calibration, Computer Hardware, Computer Skills, Computer Software, Consumer Marketing, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Customer Relations, Data Processing, Engineering, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Genetics, Healthcare, Heavy Lifting, ISO (International Organization for Standardization), ISO 9001, Injection Molding, Instrumentation, Internal Audit, Machine Tool, Manufacturing Analysis, Manufacturing Engineering, Manufacturing Management, Medical Equipment, Medical Products, Military, Mold Design, Personal Care, Physical Demands, Procedure Development, Process Manufacturing, Product Testing, Production Systems, Production Volume, Project/Program Management, Quality Assurance, Quality Management, Regulatory Compliance, Requirements Management, Root Cause Analysis, Spreadsheets, Testing, Tool and Die Manufacturing, Training Program, United States Department of Energy (DOE), Vendor/Supplier Evaluation, Warehousing, Word Processing
Alltrista Plastics LLC is a subsidiary of Jadex Inc. and is a leading manufacturer in high-volume precision injection molded parts. The company designs and manufactures with proprietary engineering processes and extensive manufacturing capabilities from five locations worldwide. From the first spark of an idea through the design of the mold to the actual manufactured product, Alltrista Plastics focuses all efforts on delivering innovative plastic solutions. The companys core markets include Consumer Products, Medical/Healthcare, Personal Care, Health & Beauty, Caps & Closures, and Packaging.
Position Summary
Responsible for GMP, ISO, FDA compliance as applicable during project management and transition to manufacturing; assures customer specification and inspection methods are understood and in compliance throughout engineering project into production. Responsible for auditing quality system.
Primary Functions
- Interfaces with customers along with Quality Manager to understand and communicate product requirements and inspection requirements for new and customer-supplied mold projects.
- Develops and executes procedures for product and equipment Process Validations: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) of new and customer-supplied molds.
- Coordinates, develops, and writes product and custom equipment inspection and calibration plans for new and customer-supplied molds.
- Helps establish and implement strong quality systems, internal auditing, supplier approval, tooling PM, facility PM program, calibration, training, and CAPA program.
- Evaluates product from DOE activities to prepare for and support parametric release and quality assurance.
- Performs and documents First Article Protocol inspections for new customer-supplied and modified molds.
- Uses SPC software to collect and evaluate process data for continual improvement.
- Conducts routine audits, evaluations, and analysis of manufacturing engineering, tooling, and warehousing activities to assess compliance with FDA or other customer-specific regulatory compliance.
- Continually updates knowledge of current state-of-the-art inspection, testing, instrumentation, and techniques and integrates into existing methods and programs.
Key Qualifications
- Associate or Bachelor Degree preferred.
- Three to five years experience in process, final, raw materials inspection experience in a high-volume production environment.
- Three to five years experience in SPC, sampling, auditing, reading blueprints, 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 LANCIM 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 Devices.
Physical Requirements
The conditions herein are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions. Please refer to the Physical Job Description which is contained as a separate document for more detail.
Environment
Normal manufacturing environments; work with machinery and media in or around confined spaces; exposure to chemicals, grease, and oils.
Physical
Sufficient physical ability to perform heavy lifting and carrying, reaching, kneeling, crawling, climbing, standing for moderate periods of time.
Vision
See in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents.
Hearing
Hear in the normal audio range with or without correction.
Other
Ability to work overtime or occasionally on weekends with short notice.
Jadex Inc. and its Businesses do not discriminate in employment based on race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.