Quality Controller

JR United Kingdom; Stoke-on-Trent; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading company in innovative tissue-healing technologies is seeking a QA/QC Responsible to conduct essential quality assurance functions. The role involves document management, product release planning, and collaboration with cross-functional teams in a manufacturing environment. Candidates should have relevant experience and qualifications, particularly in the medical device sector.

Qualifications

• Experience in a manufacturing environment, preferably in medical device QA/QC.
• Ability to read and understand technical documents and standards.
• Desirable: Knowledge of ISO13485 & FDA QSR.

Responsibilities

• Conduct QA/QC functions including inspections and testing.
• Develop and maintain documentation for Quality Management System.
• Train staff and maintain quality procedures.

Skills

Attention to detail

Organizational skills

Communication skills

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 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.

Since 2019, AMS has made seven acquisitions, expanding its portfolio and expertise globally. Its products are manufactured across several countries including the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic, and Israel, and sold worldwide through partners, distributors, and direct sales teams. AMS has R&D hubs in the UK, Ireland, Germany, France, and Israel. Established in 1991, AMS 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.

Job Role: QA/QC Responsible

This role involves conducting all QA/QC functions, prioritizing demands, working according to SOPs and PWIs, and reporting non-conformances or deviations through appropriate channels.

What will this role involve?

• Product release planning, performing goods receiving inspection & testing, in-process inspection and testing, and final product release.
• Developing, generating, maintaining, and auditing documentation to support an effective and compliant Quality Management System, including Device History Records, Material and Product Specifications, Test Records, and in-process & product release testing.
• Updating and maintaining Quality procedures, test methods, and instructions. Training others as required.

Qualifications and Skills:

• Experience 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.
• Desirable: Experience in the medical device industry, knowledge of ISO13485 & FDA QSR requirements, City & Guilds 743 or equivalent, statistical knowledge, knowledge of quality techniques and implementation, GMP, GLP, and Quality Systems, strong attention to detail, good organizational and communication skills, and adaptability.

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