Cook Group

Medical devices for minimally invasive care

Quality Control Inspector

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeLimerick, IrelandNo salary listedIn-person

About the Job

Requirements

Previous experience in medical devices is advantageous but not essential.
Ability to work flexible hours and days.
Willingness and availability to travel on company business.

Responsibilities

Inspect manufactured products according to the relevant finished quality control instructions and verify they meet quality specifications before shipment to customers.
Inspect raw materials received on site according to the relevant incoming quality control instructions and verify they meet quality specifications before release for manufacturing.
Inspect finished goods packaging according to the relevant packaging quality control instructions and verify it meets quality specifications.
Inspect products after completion of the sterilisation cycle according to the relevant instructions and verify they meet quality specifications before shipment to customers.
Review device history records according to Batch Release procedures and ensure they are compliant before product is released to stock.
Comply with good manufacturing practices, including correct gowning, CMA rules, line clearance procedures, established procedures, and accurate paperwork completion.
Highlight potential issues to Team Leaders.
Contribute to overall quality control group KPI targets by achieving daily and weekly quality and output targets.
Work as part of a quality control team within the Controlled Manufacturing Areas.
Consider Cook’s Code of Conduct in all business matters carried out on Cook’s behalf.

Desired Qualifications

Good communication and interpersonal skills.
Previous experience in medical devices.

Overview

The primary function of this role is the inspection of raw materials (IQC), finished devices (FQC), packaged devices (PKQC) , sterilised devices (PSQC) and device history records (Batch Release) ensuring that inspection procedures are followed at all times and that all product and paperwork passes specified quality control requirements before shipping to customers.

Reporting to: Supervisor, Quality Control

Find out more about Cook Medical here

Responsibilities

Ensure that all products which are manufactured at Cook Medical are inspected as per the relevant FQC instructions and that it meets the required quality control specifications before it is shipped to customers.
Ensure that all raw materials received on site at Cook Medical are inspected as per the relevant IQC instructions and that they meet the required quality control specifications before release for use in manufacturing.
Ensure that finished goods packaged at Cook Medical are inspected as per the relevant packaging quality control instructions and that they meet the required quality control specifications.
Ensure that product which has completed the sterilisation cycle is inspected as per the relevant instructions and that its meets the quality control specifications before it is shipped to customers.
Ensure that all device history records are reviewed in line with Batch Release procedures and are compliant before product is released to stock.
Ensure compliance with GMP practices i.e. gowning correctly, adhering to CMA rules, adhering to relevant line clearance procedures, following procedures and completion of paperwork accurately.
Highlight any potential issues to Team Leaders.
Contribute to attainment of overall KPI targets for the QC group by achieving daily/weekly quality and output targets.
Working as part of a QC team within the Controlled Manufacturing Areas.
Ensure that Cook’s Code of conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

Previous experience in medical devices, while not essential is advantageous.
Good communication and inter-personal skills.
Ability to work as part of a team.
Some flexibility as regards working hours/days.
Willingness and availability to travel on company business.

About the Company

Cook Group

Medical devices for minimally invasive care

Cook Group manufactures medical devices focused on minimally invasive procedures. Its Cook Medical division develops and produces a broad portfolio—over 16,000 products—across cardiology, urology, gastroenterology, endoscopy, and vascular care. The company sells to hospitals and clinics worldwide, operating a B2B model in about 135 countries, with a European footprint centered in Ireland. As a family-owned business led by Carl Cook, it aims to support clinicians with reliable technologies and clinical support to expand alternatives to open surgery.

Company size: 5,001-10,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Paris, France
Founded: 1963

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