Quality Controller

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

Job summary

Une entreprise leader dans le développement de technologies de guérison des tissus recherche un professionnel en contrôle qualité pour assurer la conformité des produits médicaux. Ce poste implique la planification de la libération des produits, l'audit de la documentation et la formation au sein d'une équipe dynamique. Les candidats doivent avoir une expérience dans un environnement médical et les qualifications requises, incluant GCSE et City & Guilds. Vous participerez à un processus d'amélioration continue des normes de qualité.

Qualifications

• Expérience antérieure en contrôle qualité ou assurance qualité dans un environnement de fabrication, de préférence dans les dispositifs médicaux.
• Connaissance des exigences ISO13485 et des règlements FDA.
• Connaissance des techniques de qualité de classe mondiale.

Responsibilities

• Planification de la libération des produits et inspection des marchandises.
• Développement et maintenance de la documentation du système de gestion de la qualité.
• Formation des autres sur les procédures de qualité.

Skills

Attention au détail

Compétences organisationnelles

Excellentes compétences en communication

Education

5 GCSE’s ou équivalent incluant Maths/English

City & Guilds 743 ou équivalent

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, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see www.admedsol.com

AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.

What will this role involve?

• Product Release Planning / performing Goods Receiving inspection & testing. In-process inspection and testing, and testing for final product release. Any other reasonable requirement as required to meet the business objectives.
• Develop, generate, maintain and audit documentation to support an effective and compliant Quality Management System including; Device History records, Material and Product Specifications, Test records, In-process & product release testing, accurately recording data, calculation of results.
• Generate, update and maintain Quality procedures, test methods, instructions. To train others as required.

Qualifications and experience:

• Background in a manufacturing environment (medical device preferred), previous QC/QA experience, with appropriate qualifications of 5 GCSE’s or equivalent including Maths/English.
• Ability to read, analyze, and understand drawings / procedures / standards.
• Experience in the medical device industry / Knowledge of ISO13485 & FDA QSR requirements.
• City & Guilds 743 or equivalent. Statistical knowledge. Knowledge of world class quality techniques and implementation. Knowledge of Good Manufacturing Practice, Good Laboratory Practice and Quality Systems.
• Strong attention to detail. Good organisational skills. Able to manage own time effectively, prioritise tasks and deliver to critical deadlines. Good communication skills; written, verbal and presenting. Flexible and adaptable to changing work environment.