Quality Controller

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

Job summary

A leading company in innovative medical device manufacturing is seeking a Quality Assurance/Quality Control specialist. This role involves overseeing QA/QC functions, ensuring compliance with QA standards, and maintaining documentation for effective quality management. Candidates should have relevant experience in a manufacturing environment, particularly in medical devices, and strong attention to detail.

Qualifications

• Experience in manufacturing environment, preferably medical devices.
• Knowledge of ISO13485 & FDA QSR requirements.
• Ability to read and understand technical documents.

Responsibilities

• Conducting all QA/QC functions and prioritizing demands.
• Product release planning and performing goods receiving inspections.
• Maintaining and auditing Quality Management System documentation.

Skills

Attention to detail

Organizational skills

Effective time management

Communication skills

Education

5 GCSEs including Maths/English

City & Guilds 743 or equivalent

Tools

Quality Management System (QMS)

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, as well as white label products.

Since 2019, AMS has made seven acquisitions, including Sealantis, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll, and Peters Surgical, expanding its expertise and product portfolio. AMS's products are manufactured in multiple countries and sold globally through various channels. The group has R&D hubs in the UK, Ireland, Germany, France, and Israel, and employs over 1,500 staff.

AMS is committed to providing equal employment opportunities and values diversity in its workforce, ensuring no discrimination based on gender, race, age, nationality, disability, or other protected characteristics.

Role Overview:

• Responsible for conducting all QA/QC functions and prioritizing demands.
• Working according to SOPs and PWIs, reporting non-conformances or deviations through appropriate channels.

Key Responsibilities:

• Product release planning, performing goods receiving inspection and testing, in-process inspection, testing, and final product release.
• Developing, 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.
• Creating, updating, and maintaining quality procedures, test methods, and instructions; training others as required.

Qualifications & Skills:

• Grounding in a manufacturing environment, preferably medical devices, with previous QC/QA experience and appropriate qualifications (e.g., 5 GCSEs including Maths/English).
• Ability to read, analyze, and understand drawings, procedures, and standards.
• Ability to represent the department in cross-functional interactions.
• Experience in the medical device industry, knowledge of ISO13485 & FDA QSR requirements, City & Guilds 743 or equivalent, statistical knowledge, and familiarity with quality techniques and GMP, GLP, and QMS standards.
• Strong attention to detail, organizational skills, effective time management, and good communication skills. Flexibility and adaptability to changing environments.