Quality Controller

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

Job summary

A leading company in the medical device sector seeks a QA/QC Responsible to oversee quality assurance and control functions. This role requires a candidate with experience in manufacturing, particularly within medical devices, as well as strong analytical and communication skills. You will be responsible for product release and documentation support for the Quality Management System, ensuring regulatory compliance and quality standards are maintained.

Qualifications

• Experience in a manufacturing environment, preferably medical devices.
• Ability to read and analyze drawings and procedures.
• Strong organizational skills and attention to detail.

Responsibilities

• Conducting all QA/QC functions and reporting non-conformances.
• Product release planning and performing goods receiving inspection.
• Updating quality procedures and training others.

Skills

Attention to Detail

Organizational Skills

Time Management

Communication Skills

Education

5 GCSEs or equivalent including Maths and English

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, 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, including Sealantis, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll, and Peters Surgical. AMS’s products are manufactured across multiple countries and sold globally via a network of partners, distributors, and direct sales in key regions. The company has R&D hubs in the UK, Ireland, Germany, France, and Israel, and was established in 1991 with over 1,500 employees.

AMS is committed to equal employment opportunities and values diversity across its workforce, 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, testing, and final product release.
• Developing, maintaining, and auditing documentation supporting the Quality Management System, including Device History Records, Material and Product Specifications, and Test Records.
• Updating and maintaining quality procedures, test methods, and instructions, and training others as required.

Qualifications and Skills:

• Experience in a manufacturing environment (medical device preferred), with appropriate qualifications including 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 ISO 13485 & FDA QSR requirements, City & Guilds 743 or equivalent, statistical knowledge, knowledge of quality techniques, GMP, GLP, and quality systems.
• Strong attention to detail, good organizational skills, effective time management, and excellent communication skills.
• Flexible and adaptable to changing environments.