Quality Engineer - Saint Charles, United States - AJR Enterprises, LLC.

AJR Enterprises, LLC. Saint Charles, United States

1 week ago

Description

Job Description

This position ensures that the quality related engineering needs of the organization are met. Responsibilities include compliance and risk analysis, process validation, pFEMA's, IQ, OQ, PQ and PPQ validation, CAPA and etc. Position works in collaboration with operations, supply chain, and new product development teams.

Position Description/Responsibilities:

Lead in supporting compliance for medical device manufacturer in ID/Traceability throughout supply chain, well documented and executed Acceptance Activities, Non-conforming material management, Packaging/Labeling control, Production/Process controls, Process Validation.
Risk Assessments, project meetings, pilot builds, First Article Inspections, and Post Market Risk Management
Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
Design and execution of pFEMA's, IQ, OQ, PQ and PPQ validation
Corrective and Preventive Action management, facilitation, ownership and problem resolution
Process improvement and support, including Quality System process review and revision.
Training assistance, including providing training in quality system activities/requirements
Internal and external audit coordination and facilitation

Requirements:

A Bachelor's degree in science, engineering or equivalent
10 or more year's relevant experience
At least 5 years' experience in medical device manufacturing
Strong knowledge of Quality Systems policies and regulations (ISO 13485 and FDA Part 820) with a strong background in medical device quality assurance and processes
Experience conducting supplier audits and writing supplier contracts.
Familiarity with statistical analysis.

Company DescriptionAJR Enterprises, LLC is a leading contract manufacturer of superior medical devices and advanced manufacturing solutions within the medical device industry. Headquarters and manufacturing are located at our 180,000 square foot facility in St. Charles, Illinois.

We are focused on delivering the highest quality products and providing exceptional customer satisfaction in the medical device industry.

Company Description

AJR Enterprises, LLC is a leading contract manufacturer of superior medical devices and advanced manufacturing solutions within the medical device industry. Headquarters and manufacturing are located at our 180,000 square foot facility in St. Charles, Illinois.\r
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We are focused on delivering the highest quality products and providing exceptional customer satisfaction in the medical device industry.

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