Quality Controller

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

Job summary

A leading company in medical devices seeks a Quality Control Specialist to ensure compliance and quality of products. The role involves product release planning, inspections, and maintaining quality documentation. Ideal candidates will have experience in a manufacturing setting, particularly in the medical devices sector, along with strong analytical and communication skills.

Qualifications

• Experience in a manufacturing environment, preferably in medical devices.
• Knowledge of ISO13485 & FDA QSR requirements is desirable.

Responsibilities

• Perform Goods Receiving inspection & testing.
• Develop and audit Quality Management System documentation.
• Train others in quality procedures and testing methods.

Skills

Attention to Detail

Organizational Skills

Communication Skills

Education

5 GCSE’s or equivalent including Maths/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, 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 the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic, and Israel, and sold globally via a network of partners and distributors, as well as direct sales in various countries. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel. Established in 1991, it has more than 1,500 employees. For more information, visit www.admedsol.com.

AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce, meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.

What will this role involve?

• Product Release Planning / performing Goods Receiving inspection & testing.
• In-process inspection and testing, and testing for final product release. Any other reasonable requirements as needed to meet business objectives.
• Develop, generate, maintain, and audit documentation to support an effective and compliant Quality Management System, including Device History records, Material and Product Specifications, Test records, In-process & product release testing, with accurate data recording and calculation of results.
• Generate, update, and maintain Quality procedures, test methods, and instructions. Train others as required.

Qualifications and experience:

• Ground in a manufacturing environment (medical device preferred), previous QC/QA experience, with appropriate qualifications of 5 GCSE’s or equivalent including Maths/English.
• Ability to read, analyze, and understand drawings/procedures/standards.
• Desirable: Experience in medical device industry, knowledge of ISO13485 & FDA QSR requirements, City & Guilds 743 or equivalent, statistical knowledge, knowledge of world-class quality techniques and implementation, knowledge of GMP, GLP, and Quality Systems. Strong attention to detail, good organizational skills, ability to manage time effectively, prioritize tasks, and meet deadlines. Good communication skills; written, verbal, and presenting. Flexible and adaptable to changing environments.