Quality Controller

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

Job summary

A leading company in innovative tissue-healing technology is seeking a Quality Assurance professional. In this role, you will conduct QA/QC functions, manage quality documentation, and ensure compliance with ISO and FDA standards. Candidates should have experience in manufacturing, especially within the medical device sector, and possess strong communication and organizational skills.

Qualifications

• Experience in a manufacturing environment, preferably medical devices.
• Ability to read and understand technical drawings and standards.
• Knowledge of quality management systems.

Responsibilities

• Conduct QA/QC functions and prioritize demands.
• Product release planning and goods receiving inspection.
• Develop and maintain documentation for the Quality Management System.

Skills

Communication

Organizational Skills

Time Management

Education

5 GCSEs or equivalent

Tools

ISO13485

FDA QSR requirements

Good Manufacturing Practice

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 multiple countries and sold globally via a network of partners, distributors, and direct sales forces. The Group has R&D hubs across several countries and was established in 1991 with over 1,500 employees. 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 QA/QC functions and prioritize demands.
• Work according to SOPs and PWIs, report non-conformances or deviations.
• Product release planning, goods receiving inspection & testing, in-process inspection, and final product release testing.
• Develop, maintain, and audit documentation supporting the Quality Management System, including Device History Records, specifications, test records, and data.
• Update and maintain quality procedures, test methods, and instructions; train others as needed.

Qualifications and Skills:

• Experience in a manufacturing environment (medical device preferred), with appropriate qualifications including 5 GCSEs or equivalent, especially in Maths/English.
• Ability to read and understand drawings, procedures, and standards.
• Strong communication skills, organizational skills, and the ability to manage time effectively.
• Knowledge of ISO13485 & FDA QSR requirements, Good Manufacturing Practice, and quality techniques.
• Desirable: experience in the medical device industry, statistical knowledge, and familiarity with quality systems.