Quality Engineer

Alltrista Plastics LLC; Greenville (SC); On-site; USD 50,000 - 70,000; Full time

Job summary

A manufacturing company in South Carolina is seeking a Quality Assurance Specialist who will ensure compliance with GMP, ISO, and FDA standards. The ideal candidate has 3-5 years of experience in inspections within a high-volume production environment, and is knowledgeable in quality management systems. This role involves auditing quality systems, developing validation procedures, and coordinating inspections, alongside the ability to utilize various quality tools and technologies.

Qualifications

• Three to five years experience in inspection in a high-volume production environment.
• Experience with control charts, capability studies, and statistical tools.
• Knowledge of ISO 9001/QMS and ISO 13485.

Responsibilities

• Audits quality systems for GMP, ISO, and FDA compliance.
• Coordinates and writes inspection plans for molds.
• Develops product and equipment validation procedures.

Skills

GMP

ISO compliance

FDA regulations

SPC

quality auditing

blueprint reading

root cause analysis

Education

Associate or bachelor's degree

Tools

SPC software

LAN/CIM

statistical software

graphical spreadsheets

word processing software

Job description

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.
• 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.

Key Qualifications

• Associate or bachelor's 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 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.

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.