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Quality controller

Newport (Newport)
JR United Kingdom
Quality controller
€60,000 - €80,000 a year
Posted: 10 June
Offer description

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AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand, RESORBA, LiquiBandFix8, LIQUIFIX, Peters Surgical, Ifabond, Vitalitec and Seal-G. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll, and Peters Surgical. AMS's products are manufactured in multiple countries and sold globally through various channels. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel, and employs over 1,500 staff. For more information, visit www.admedsol.com.

AMS provides equal employment opportunities for all applicants, valuing diversity and prohibiting discrimination based on protected characteristics.

Role Responsibilities:

* Conduct QA/QC functions and prioritize tasks based on demands.
* Follow SOPs and PWIs, report non-conformances or deviations through appropriate channels.
* Product release planning, performing goods receiving inspections and testing.
* Conduct in-process and final product testing for release.
* Develop, maintain, and audit documentation supporting the Quality Management System, including Device History Records, Material and Product Specifications, Test Records, and In-process & Product Release Testing.
* Generate, update, and maintain quality procedures, test methods, and instructions.
* Train others as required.

Qualifications and Skills:

* Experience in a manufacturing environment (medical device preferred), with appropriate qualifications such as 5 GCSEs or equivalent, including Maths and English.
* Ability to read, analyze, and understand drawings, procedures, and standards.
* Ability to represent the department in cross-functional interactions.
* Desirable: Experience in the medical device industry, knowledge of ISO13485 & FDA QSR requirements, City & Guilds 743 or equivalent, statistical knowledge, and familiarity with quality techniques and GMP, GLP, and Quality Systems.
* Strong attention to detail, good organizational skills, and effective time management.
* Excellent communication skills, both written and verbal.
* Flexible and adaptable to changing environments.
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