Quality Controller

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

Job summary

A leading company in medical device manufacturing is seeking a QA/QC professional to oversee quality assurance and control processes. The successful candidate will conduct inspections, maintain documentation, and ensure compliance with quality standards. Ideal candidates will have a background in QA/QC, strong analytical skills, and experience in a manufacturing environment.

Qualifications

• Experience in a manufacturing environment, preferably medical devices.
• QA/QC experience required.
• Ability to read and understand drawings and standards.

Responsibilities

• Conducting QA/QC functions and reporting non-conformances.
• Performing goods receiving inspections and testing.
• Developing and auditing quality documentation.

Skills

Attention to detail

Organizational skills

Effective time management

Good communication skills

Education

5 GCSEs or equivalent including Maths and English

Tools

Statistical knowledge

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, both branded and white label.

Since 2019, AMS has made seven acquisitions, including Sealantis, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll, and Peters Surgical. These products are manufactured across various countries including the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic, and Israel, and sold globally through regional partners, distributors, and direct sales forces. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel, and has more than 1,500 employees.

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

Role Overview:

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

Key Responsibilities:

• Product release planning, performing goods receiving inspection and testing.
• Inspection and testing for final product release, and other duties to meet business objectives.
• Developing, maintaining, and auditing documentation such as Device History Records, Material and Product Specifications, Test records, and In-process & product release testing data.
• 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 QA/QC experience and at least 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, and familiarity with quality techniques and GMP, GLP, and quality systems.
• Strong attention to detail, organizational skills, effective time management, good communication skills, and adaptability to changing environments.

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• Ground in manufacturing, previous QC/QA experience, appropriate qualifications, ability to interpret drawings and standards, and effective communication skills are essential.