Quality Controller

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

Job summary

A leading company in innovative tissue-healing technology is seeking a Quality Assurance professional. The role involves conducting QA/QC functions, maintaining documentation, and ensuring compliance with quality standards. Applicants should have experience in a manufacturing environment, ideally within the medical device industry, and possess strong organizational and communication skills.

Qualifications

• Experience in a manufacturing environment (medical device preferred).
• Knowledge of ISO13485 & FDA QSR requirements is desirable.
• Strong attention to detail and good organizational skills.

Responsibilities

• Conduct QA/QC functions and perform product release planning.
• Develop and audit documentation for the Quality Management System.
• Train others and maintain quality procedures.

Skills

Attention to detail

Organizational skills

Communication skills

Analytical skills

Time management

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 the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic, and Israel, and are sold globally via a network of partners and distributors, as well as through AMS's direct sales forces in multiple countries. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel. Established in 1991, the Group employs over 1,500 staff. For more information, visit www.admedsol.com.

AMS provides equal employment opportunities for all applicants, valuing diversity and ensuring no discrimination based on gender, race, age, nationality, disability, or other protected characteristics as per law.

Role Responsibilities:

• Conduct QA/QC functions, prioritize demands, and work according to SOPs and PWIs.
• Report non-conformances or deviations through appropriate channels.
• Perform product release planning, goods receiving inspection, testing, and final product release.
• Develop, maintain, and audit documentation supporting the Quality Management System, including Device History Records, Material and Product Specifications, Test Records, and In-process & product release testing.
• Update and maintain quality procedures, test methods, and instructions.
• Train others as required and perform other reasonable duties to meet business objectives.

Qualifications and Skills:

• Experience in a manufacturing environment (medical device preferred), with appropriate qualifications such as 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 understanding of quality techniques and GMP, GLP, and Quality Systems.
• Strong attention to detail, good organizational skills, and effective time management.
• Excellent communication skills, both written and verbal, and adaptability to changing environments.