Quality Controller

JR United Kingdom; Shrewsbury; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading company in innovative tissue-healing technology seeks a skilled QA/QC professional to oversee quality assurance and compliance functions. The role involves product release planning, documentation management, and ensuring adherence to quality standards. Candidates must have previous QC/QA experience and solid GCSE qualifications, ideally in a manufacturing context, particularly within the medical device sector.

Qualifications

• Experience in a manufacturing environment with previous QC/QA experience.
• Knowledge of ISO13485 and FDA QSR requirements is desirable.
• Statistical knowledge and familiarity with quality techniques.

Responsibilities

• Conducting all QA/QC functions, prioritizing tasks based on demands.
• Product release planning, goods receiving inspection, and testing.
• Maintaining and auditing documentation for Quality Management System.

Skills

Strong communication and organizational skills

Flexibility and adaptability

Ability to read and understand procedures

Education

5 GCSEs or equivalent, including Maths and English

Job description

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 white label products.

Since 2019, AMS has made seven acquisitions, including Sealantis, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll, and Peters Surgical. Its 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 forces. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel, and employs over 1,500 staff.

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

Role Overview:

The successful candidate will be responsible for conducting all QA/QC functions, prioritizing tasks based on demands, working according to SOPs and PWIs, and reporting non-conformances or deviations through the appropriate channels.

Key Responsibilities:

• Product release planning, goods receiving inspection, and testing.
• In-process inspection and testing, 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 and final release testing data.
• Update and maintain Quality procedures, test methods, and instructions; train others as required.

Candidate Requirements:

• Experience in a manufacturing environment (medical device preferred) with previous QC/QA experience.
• Qualifications: 5 GCSEs or equivalent, including Maths and English.
• Ability to read, analyze, and understand drawings, procedures, and standards.
• Strong communication and organizational skills; ability to manage time effectively and prioritize tasks.
• Flexibility and adaptability to changing environments.

Desirable qualifications include experience in the medical device industry, knowledge of ISO13485 and FDA QSR requirements, City & Guilds 743 or equivalent, statistical knowledge, and familiarity with quality techniques and GMP, GLP, and quality systems.