Quality Controller

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

Job summary

A leading company in medical device manufacturing seeks a quality control specialist in Swindon. The role involves product release planning, inspection, and maintaining quality documentation. Ideal candidates will have experience in manufacturing environments, particularly within medical devices, and relevant qualifications such as GCSEs.

Qualifications

• Experience in a manufacturing environment (medical device preferred).
• Knowledge of ISO13485 & FDA QSR requirements.
• Understanding of Good Manufacturing and Laboratory Practices.

Responsibilities

• Product release planning and goods receiving inspection.
• Developing and maintaining documentation for Quality Management System.
• Training others in quality procedures and standards.

Skills

Attention to detail

Organizational skills

Communication skills

Statistical knowledge

Education

5 GCSEs including Maths/English

City & Guilds 743 or equivalent

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 a network of partners, distributors, and direct sales forces. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel, and was established in 1991 with more than 1,500 employees. For more information, see www.admedsol.com.

AMS provides equal employment opportunities and values diversity, ensuring no discrimination based on gender, race, age, nationality, disability, or other protected characteristics.

What will this role involve?

• Product release planning and performing goods receiving inspection & testing.
• Inspection and testing for final product release and other related activities to meet business objectives.
• Developing, generating, 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.
• Creating, updating, and maintaining quality procedures, test methods, and instructions. Training others as required.

The ideal candidate will have:

• Grounding in a manufacturing environment (medical device preferred), with previous QC/QA experience and appropriate qualifications such as 5 GCSEs or equivalent including Maths/English.
• Ability to read, analyze, and understand drawings, procedures, and standards.
• Ability to represent the department in cross-functional interactions.
• Experience in the medical device industry, knowledge of ISO13485 & FDA QSR requirements, City & Guilds 743 or equivalent, statistical knowledge, and understanding of quality techniques and implementation.
• Knowledge of Good Manufacturing Practice, Good Laboratory Practice, and Quality Systems.
• Strong attention to detail, good organizational skills, and the ability to manage time effectively, prioritize tasks, and meet deadlines.
• Good communication skills, flexibility, and adaptability to changing environments.