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.
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.
Help 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/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.
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 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 Devices.
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.
The above statements describe the general nature and level of responsibilities for this position, and are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position. Company management may assign other relevant, business-related duties.
We are experts in the medical, pharma, nutraceutical, specialty packaging, and high-end consumer markets. In short, a lot of people depend on us, and we always deliver. We are vertically integrated so that each stage of our manufacturing process is a testing ground for cross-disciplinary methods and internal research. This foundation gives us the incredible ability to integrate material science, machine, and automation manufacturing technologies for exceptional results.
SPE US Office 100 Reserve Rd. Suite B310
Danbury, CT 06810
P +1 203.740.5400
F +1 203.740.5405
P +32 498 85 07 32
SPE Middle East Section Office N. ESO:14
Sheikh Rashid Tower
Dubai World Trade Center
P.O. Box 9204