Quality Controller

JR United Kingdom; Bath; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading company specializing in tissue-healing technologies is seeking an experienced QA/QC professional. This role focuses on conducting quality assurance functions, ensuring compliance with industry standards, and supporting the Quality Management System. The ideal candidate will have relevant qualifications and a background in the medical device manufacturing environment.

Qualifications

• Experience in a manufacturing environment (medical device preferred).
• Desirable: Knowledge of ISO13485 & FDA QSR requirements.

Responsibilities

• Product release planning and performing goods receiving inspection & testing.
• Updating and maintaining quality procedures, test methods, and instructions.

Skills

Attention to detail

Organizational skills

Communication skills

Time management

Education

5 GCSEs or equivalent including Maths and English

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, marketed under brands such as LiquiBand, RESORBA, LiquiBandFix8, LIQUIFIX, Peters Surgical, Ifabond, Vitalitec, and Seal-G. The company also supplies wound care dressings like silver alginates, alginates, and foams through its ActivHeal brand, as well as under white label. Since 2019, AMS has made seven acquisitions, including Sealantis, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll, and Peters Surgical. AMS's products are manufactured across various countries and sold globally through a network of partners, distributors, and direct sales in key regions. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel, and employs over 1,500 staff since its establishment in 1991. For more information, visit www.admedsol.com.

AMS is an equal opportunity employer that values diversity and prohibits discrimination based on gender, race, age, nationality, disability, or any other protected characteristic by law.

Role Overview:

This role involves conducting all QA/QC functions, prioritizing demands, working according to SOPs and PWIs, and reporting non-conformances or deviations through appropriate channels.

Key Responsibilities:

• Product release planning and performing goods receiving inspection & testing.
• In-process inspection and testing, final product release testing, and other duties to meet business objectives.
• Developing, maintaining, and auditing documentation supporting the Quality Management System, including Device History Records, Material and Product Specifications, Test Records, and In-process & product release testing data.
• Updating and maintaining quality procedures, test methods, and instructions; training others as required.

Qualifications and Skills:

• Experience in a manufacturing environment (medical device preferred), with relevant QA/QC qualifications, including at least 5 GCSEs or equivalent, including Maths and 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 requirements, City & Guilds 743 or equivalent, statistical knowledge, and familiarity with quality techniques and GMP, GLP, and QMS standards.
• Strong attention to detail, organizational skills, effective time management, and good communication skills.
• Flexible and adaptable to changing work environments.

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