Quality Controller

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

Job summary

Une entreprise leader dans le secteur des dispositifs médicaux recherche un Technicien QA/QC pour assurer toutes les fonctions d'assurance qualité et de contrôle qualité. Le candidat idéal devra avoir de l'expérience en environnement de fabrication et des qualifications QA/QC pertinentes, tout en étant capable de travailler selon des procédures strictes et de former d'autres membres de l'équipe.

Qualifications

• Expérience en environnement de fabrication (dispositif médical de préférence) avec expérience QA/QC pertinente.
• Connaissance des exigences ISO13485 et FDA QSR.
• Compétences en représentation inter-départementale.

Responsibilities

• Planification de la libération des produits, inspection des réceptions et tests.
• Maintenir et auditer la documentation pour un système de gestion de la qualité efficace.
• Former d'autres personnes si nécessaire.

Skills

Analytical skills

Attention to detail

Organizational skills

Communication skills

Education

5 GCSEs or equivalent (including Math 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 offers 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 and under white label. Since 2019, AMS has made seven acquisitions, expanding its portfolio and expertise across various surgical and wound care technologies. AMS's products are manufactured across multiple countries including the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic, and Israel, and are sold globally through a network of partners, distributors, and direct sales teams. The company has R&D hubs in the UK, Ireland, Germany, France, and Israel, and employs over 1,500 staff members. For more information, visit www.admedsol.com.

AMS is committed to providing equal employment opportunities and values diversity in its workforce, ensuring no discrimination based on gender, race, age, nationality, disability, or other protected characteristics.

Role Overview:

The QA/QC Technician is responsible for conducting all quality assurance and quality control functions, prioritizing demands, working according to SOPs and PWIs, and reporting non-conformances or deviations through proper channels.

Key Responsibilities:

• Product release planning, goods receiving inspection, and testing.
• In-process inspection and testing, and testing for final product release.
• Developing, maintaining, and auditing documentation to support an effective and compliant Quality Management System, including Device History Records, Material and Product Specifications, Test Records, and In-process & Product Release Testing data.
• Creating, updating, and maintaining quality procedures, test methods, and work instructions.
• Training others as required.

Qualifications and Skills:

• Experience in a manufacturing environment (medical device preferred) with relevant QA/QC experience and qualifications, including 5 GCSEs or equivalent, with Math and English.
• Ability to read, analyze, and understand drawings, procedures, and standards.
• Strong departmental representation skills 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 systems.
• Strong attention to detail, organizational skills, and the ability to manage time effectively.
• Excellent communication skills, both written and verbal, with flexibility and adaptability to changing environments.