Quality Controller

JR United Kingdom; Dartford; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading company in the medical device sector is seeking a QA/QC professional to ensure compliance and quality in its innovative products. The position involves conducting inspections, maintaining quality standards, and developing relevant documentation. Ideal candidates will have a strong attention to detail and be well-versed in quality management systems within the manufacturing environment.

Qualifications

• Experience in a manufacturing environment, preferably medical device.
• Ability to read and understand drawings and procedures.
• Desirable: knowledge of ISO13485 & FDA QSR.

Responsibilities

• Conduct QA/QC functions and prioritize demands.
• Perform goods receiving inspection and testing.
• Develop and maintain documentation for effective Quality Management System.

Skills

Attention to detail

Organizational skills

Effective time management

Communication skills

Adaptability

Education

5 GCSEs or equivalent with 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 various countries and sold globally via multiple channels. 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 gender, race, age, nationality, disability, or other protected characteristics.

Role Responsibilities:

• Conduct all QA/QC functions and prioritize demands.
• Follow SOPs and PWIs, report non-conformances or deviations through appropriate channels.
• Product release planning, performing goods receiving inspection & testing, including in-process and final product testing.
• Develop, generate, maintain, and audit documentation supporting an effective and compliant Quality Management System, including Device History Records, Material and Product Specifications, Test Records, and release testing data.
• Update and maintain quality procedures, test methods, and instructions; train others as required.

Qualifications and Skills:

• Experience in a manufacturing environment (medical device preferred), with appropriate qualifications including 5 GCSEs or equivalent with Maths/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, 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, good communication skills, and adaptability.