Quality Controller

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

Job summary

A leading company specializing in innovative tissue-healing technology seeks a QA/QC professional. The role involves ensuring product quality through inspections, documentation, and adherence to regulatory standards in the medical device sector. Ideal candidates will have relevant experience and qualifications, focusing on maintaining high-quality outcomes.

Qualifications

• Grounding in a manufacturing environment with previous QC/QA experience.
• Ability to read and understand drawings, procedures, and standards.
• Preferred: Knowledge of ISO13485 & FDA QSR requirements.

Responsibilities

• Conducting all QA/QC functions including product release planning and inspection.
• Developing and maintaining documentation for the Quality Management System.
• Updating quality procedures and providing training as needed.

Skills

Attention to detail

Organizational skills

Effective time management

Strong communication skills

Education

5 GCSEs or equivalent including Maths and English

City & Guilds 743 or equivalent

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 has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices, and internal sealants, marketed under brands like LiquiBand, RESORBA, LiquiBandFix8, LIQUIFIX, Peters Surgical, Ifabond, Vitalitec, and Seal-G. The company also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal brand and white label. Since 2019, AMS has made seven acquisitions, expanding its portfolio and capabilities. The group’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 forces. Established in 1991, AMS employs over 1,500 staff and has R&D hubs in the UK, Ireland, Germany, France, and Israel. The company values diversity and provides equal employment opportunities. The role involves conducting all QA/QC functions, prioritizing demands, working according to SOPs and PWIs, and reporting non-conformances or deviations. What will this role involve?

1. Product release planning, goods receiving inspection & testing, in-process inspection, testing, and final product release. Other reasonable requirements to meet business objectives.
2. Developing, maintaining, and auditing documentation to support the Quality Management System, including Device History Records, Material and Product Specifications, Test Records, and In-process & product release testing, ensuring accurate data recording and calculation of results.
3. Updating and maintaining quality procedures, test methods, and instructions. Training others as required.

Qualifications and experience required include:

• Grounding in a manufacturing environment (medical device preferred), with previous QC/QA experience and appropriate qualifications such as 5 GCSEs or equivalent including Maths and English.
• Ability to read, analyze, and understand drawings, procedures, and standards.
• Ability to represent the department in cross-functional interactions.
• Preferred: Experience in the medical device industry, knowledge of ISO13485 & FDA QSR requirements, City & Guilds 743 or equivalent, statistical knowledge, understanding of quality techniques and implementation, GMP, GLP, and Quality Systems, strong attention to detail, good organizational skills, effective time management, and strong communication skills.