Quality Controller

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

Job summary

A leading company in the medical devices sector is looking for a QA/QC professional to manage quality assurance functions. The role involves product release planning, documentation maintenance, and training staff in quality management standards. Candidates should have experience in a manufacturing environment, preferably in medical devices, with a focus on attention to detail and strong communication skills.

Qualifications

• Experience in a manufacturing environment, preferably medical devices.
• Desirable: knowledge of ISO13485 & FDA QSR, GMP, GLP, Quality Systems.

Responsibilities

• Conduct QA/QC functions and prioritize demands.
• Perform product release planning and goods receiving inspection.
• Develop and maintain documentation for the Quality Management System.

Skills

Attention to detail

Organizational skills

Effective time management

Good communication skills

Adaptability

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, 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 multiple countries and sold globally via a network of partners, distributors, and direct sales in various regions. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel, and employs over 1,500 staff.

AMS provides equal employment opportunities and values diversity, ensuring no discrimination based on protected characteristics.

Role Responsibilities:

• Conduct QA/QC functions and prioritize demands.
• Follow SOPs and PWIs, report non-conformances or deviations through proper channels.
• Perform product release planning, goods receiving inspection, and testing for final product release.
• Develop, maintain, and audit documentation supporting the Quality Management System, including Device History Records, specifications, test records, and in-process and product release testing.
• Update and maintain quality procedures, test methods, and instructions; train others as required.

Qualifications and Skills:

• Experience in a manufacturing environment (medical device preferred) or previous QC/QA experience.
• Qualifications including 5 GCSEs or equivalent, including Maths and English.
• Ability to read and analyze 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, City & Guilds 743 or equivalent, statistical knowledge, understanding of quality techniques, GMP, GLP, and Quality Systems.
• Strong attention to detail, organizational skills, effective time management, and good communication skills. Adaptable to changing environments.