Quality Controller

JR United Kingdom; Colchester; On-site; GBP 25,000 - 35,000; Full time

Job summary

A leading company in the medical device industry seeks a Quality Assurance/Quality Control specialist to ensure compliance with regulatory standards. This position involves conducting QA/QC functions, performing product testing, and maintaining quality documentation. The ideal candidate will have experience in a manufacturing environment, particularly in medical devices, and possess strong organizational skills.

Qualifications

• Experience in a manufacturing environment, preferably medical devices.
• Ability to read and understand drawings, procedures, and standards.
• Desirable: knowledge of GMP, GLP, and quality systems.

Responsibilities

• Conduct all QA/QC functions and prioritize demands.
• Perform product release activities including inspection and testing.
• Develop and maintain documentation for the Quality Management System.

Skills

Attention to detail

Organizational skills

Effective time management

Good communication skills

Statistical knowledge

Education

5 GCSEs or equivalent, including Maths/English

Tools

Quality Management Systems

ISO13485

FDA QSR

Job 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 via various channels. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel, and was established in 1991 with over 1,500 employees. For more information, see www.admedsol.com

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

Role Responsibilities:

• Conduct all QA/QC functions and prioritize demands.
• Follow SOPs and PWIs, report non-conformances or deviations appropriately.
• Perform product release activities including goods receiving inspection and testing, process inspection, and final product testing.
• Develop, generate, maintain, and audit documentation supporting the Quality Management System, such as Device History Records, Material and Product Specifications, Test Records, and In-process & Product Release Testing.
• Update and maintain quality procedures, test methods, and instructions; train others as required.

Qualifications and Skills:

• Experience in a manufacturing environment (medical device preferred) or previous QC/QA experience.
• Qualifications including 5 GCSEs or equivalent, including Maths/English.
• Ability to read 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, City & Guilds 743 or equivalent, statistical knowledge, understanding of quality techniques, GMP, GLP, and quality systems.
• Strong attention to detail, organizational skills, effective time management, and good communication skills.
• Flexible and adaptable to changing environments.