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Akkodis · 1 day ago

Quality Engineer

Bloomingdale, IL

Contract

Onsite

New Grad, Entry Level

$45/hr - $65/hr

0+ years exp

Akkodis is seeking a Quality Engineer for a 6+ Contract position. The role involves ensuring compliance with quality standards in the manufacturing of surgical instruments and implants, as well as developing and implementing inspection techniques to verify product quality.

Information Technology & Services

H1B Sponsor Likely

Responsibilities

Responsible for meeting customer requirements for the manufacturing of surgical instruments and implants or instrument delivery systems from receiving raw material to the shipping of finished goods

Supports and enforces the development of internal systems and procedures to meet ISO standards and FDA quality system regulations

Develops and implements inspection/validation techniques necessary to verify products meet requirements at earliest point in the production process

Specifies and implements new inspection equipment and instructs others in its proper use

Supports and implements systems in the areas of SPC, advanced quality, and design/development

Assists in the development and implementation of systems and processes that foster continuous improvement for product development and/or manufacturing

Responsible for ensuring cell processes are correctly base-lined & controlled

Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC

Completes the implementation and performance of gage R&R, process capability studies, design of experiments, and summaries as required to improve quality and to provide required deliverables to customers

Ensures processes released with use of SPC where applicable and/or promote the utilization of SPC

Provides SPC & ongoing monitoring of SPC

Investigates deviations, OOS, complaints, returns, recalls, and field alerts

Supports the Material Review Board (MRB) for internal non-conformances and customer returns

May lead or verify effectiveness of corrective and preventive actions (CAPAs)

Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements

Verify that all production procedures have been followed and the records such as Device Master Records and Device History Records are maintained per FDA & customer requirements and Paragon Medical requirements

Design inspection/validation steps to be taken by operations at the point of manufacture and integrate these steps into the manufacturing instructions

Responsible to create, implement and improve quality systems and procedures for meeting ISO 13485, FDA and customer quality system requirements

Work in conjunction with Cell Leaders to ensure CNC Machinists are knowledgeable and competent in the use and care of sensitive measuring equipment and related requirements such as calibration, recording of data, expected variability, etc

Provide day-to-day oversight of quality including batch testing, inspection, calibration, environmental monitoring, qualification, document review, etc

Creates and supports ECN’s and SCR’s (product)

May authorize, initiate and/or approve product and process changes

Supports both internal and external audits of all corporate quality systems and demonstrates compliance through objective evidence

Qualification

ISO 13485FDA quality systemStatistical Process Control (SPC)Gage R&RDesign of Experiments (DOE)GD&TBlueprint readingTight tolerance measurementContinuous improvementTraining personnel

Required