Quality Controller

JR United Kingdom; Chesterfield; On-site; GBP 25,000 - 40,000; Full time

Job summary

A leading company in innovative tissue-healing technology is seeking a QA/QC professional to ensure compliance with quality standards. The ideal candidate will have experience in a manufacturing environment, particularly within medical devices, and will be responsible for maintaining the Quality Management System, training others, and performing testing and inspections.

Qualifications

• Experience in a manufacturing environment with QA/QC responsibilities.
• Knowledge of ISO13485 & FDA QSR requirements.
• Flexibility and adaptability to changing environments.

Responsibilities

• Conduct QA/QC functions and prioritize tasks based on demands.
• Develop, generate, maintain, and audit documentation for the Quality Management System.
• Train others as required.

Skills

Attention to detail

Good communication skills

Organizational skills

Education

5 GCSEs 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, 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 white label products.

Since 2019, AMS has made seven acquisitions, including Sealantis, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll, and Peters Surgical. The products are manufactured across various 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 Group maintains R&D hubs in the UK, Ireland, Germany, France, and Israel. Established in 1991, AMS employs over 1,500 staff. For more information, visit www.admedsol.com.

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

Job Responsibilities:

• Conduct QA/QC functions and prioritize tasks based on demands.
• Work according to SOPs and PWIs, report non-conformances or deviations through proper channels.
• Perform product release planning, goods receiving inspection, testing, and final product release testing.
• 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 QA/QC responsibilities.
• Qualifications including 5 GCSEs or equivalent, with Maths/English.
• Ability to read and understand drawings, procedures, and standards.
• Good communication skills, both written and verbal.
• Knowledge of ISO13485 & FDA QSR requirements, statistical techniques, GMP, GLP, and quality systems.
• Strong attention to detail and organizational skills.
• Ability to manage time effectively and prioritize tasks.
• Flexibility and adaptability to changing environments.

Preferred: Experience in the medical device industry, knowledge of world-class quality techniques, and relevant certifications such as City & Guilds 743 or equivalent.