Quality Controller

JR United Kingdom; London; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading company in the medical device industry is looking for a QA/QC professional to ensure product quality and compliance. This role involves conducting various quality assurance functions, releasing products, and maintaining documentation. Candidates should have prior QA/QC experience, particularly in medical devices, and strong organizational and communication skills.

Qualifications

• Experience in a manufacturing environment, preferably medical devices, with QA/QC experience.
• Ability to read and understand drawings and standards.
• Knowledge of ISO13485 & FDA QSR requirements desired.

Responsibilities

• Conduct all QA/QC functions, prioritize demands, and report non-conformances.
• Develop, maintain, and audit documentation for the Quality Management System.
• Train others as required.

Skills

Attention to detail

Organizational skills

Communication skills

Education

5 GCSEs or equivalent 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 the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic, and Israel, and are sold globally via a network of partners, distributors, and direct sales forces in several countries. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel. Established in 1991, AMS employs over 1,500 people. For more information, visit www.admedsol.com

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

Role Responsibilities:

• Conduct all QA/QC functions and prioritize demands.
• Work according to SOPs and PWIs, report non-conformances or deviations.
• Product release planning, goods receiving inspection, and testing.
• Perform in-process inspection and testing, and testing for final product release.
• Develop, generate, 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.
• Create, 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 previous QC/QA experience and appropriate qualifications (e.g., 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.
• Desirable: Experience in the medical device industry, knowledge of ISO13485 & FDA QSR requirements, City & Guilds 743 or equivalent, statistical knowledge, understanding of quality techniques, GMP, GLP, and Quality Systems.
• Strong attention to detail, good organizational skills, and effective time management.
• Excellent communication skills (written, verbal, presentation), flexibility, and adaptability.