Quality Controller

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

Job summary

A world-leading independent developer and manufacturer in the medical device sector seeks a Quality Assurance/Quality Control specialist to oversee QA processes. The successful candidate will have experience in manufacturing, preferably within medical devices, and relevant educational qualifications. Responsibilities include product testing and documentation audits, while fostering cross-functional collaboration in the department. Attention to detail and strong organizational skills are essential for this role.

Qualifications

• Experience in a manufacturing environment, preferably medical devices.
• Ability to read and understand drawings, procedures, and standards.
• Knowledge of ISO13485 & FDA QSR is desired.

Responsibilities

• Conduct QA/QC functions and prioritize demands.
• Product release planning and final product testing.
• Develop and audit documentation supporting the Quality Management System.

Skills

Attention to detail

Organizational skills

Time management

Communication skills

Flexibility

Adaptability

Education

5 GCSEs including Maths/English

City & Guilds 743 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, 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 various channels. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel. Established in 1991, it employs over 1,500 staff. For more information, visit www.admedsol.com.

AMS provides equal employment opportunities and values diversity, ensuring no discrimination based on 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 testing.
• Develop, 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.
• Update and maintain Quality procedures, test methods, and instructions. Train others as required.

Candidate Requirements:

• Experience in a manufacturing environment, preferably medical devices, with relevant qualifications (e.g., 5 GCSEs including Maths/English).
• Ability to read and understand drawings, procedures, and standards.
• Ability to represent the department in cross-functional interactions.
• Desired: Experience in the medical device industry, knowledge of ISO13485 & FDA QSR, City & Guilds 743 or equivalent, statistical knowledge, understanding of quality techniques, GMP, GCP, and Quality Systems.
• Strong attention to detail, organizational skills, and effective time management.
• Good communication skills, flexibility, and adaptability.