Quality Controller

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

Job summary

AMS, a leader in surgical product innovation, is seeking a Quality Assurance professional to ensure product compliance and quality outcomes. The role involves conducting quality control tasks, maintaining documentation, and implementing quality systems in a dynamic manufacturing environment. Ideal candidates will have relevant experience in medical devices and strong communication skills.

Qualifications

• Experience in a manufacturing environment, ideally medical devices.
• Ability to read and analyze drawings, procedures, and standards.
• Desirable: knowledge of ISO 13485 & FDA QSR, statistical knowledge, understanding of GMP and GLP.

Responsibilities

• Conduct QA/QC functions and report non-conformances.
• Product release planning and performing goods receiving inspections.
• Develop and audit documentation for the Quality Management System.

Skills

Communication skills

Attention to detail

Organizational skills

Education

5 GCSEs 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, manufactured in multiple countries, are sold globally via a network of partners and distributors, as well as through AMS's own sales forces in key regions. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel. Established in 1991, it employs over 1,500 staff. For more information, visit www.admedsol.com

AMS is an equal opportunity employer that values diversity and prohibits discrimination based on gender, race, age, nationality, disability, or any other protected characteristic.

Role Responsibilities:

• Conduct QA/QC functions, prioritize demands, work according to SOPs and PWIs, and report non-conformances or deviations.
• Product release planning, performing goods receiving inspections, in-process testing, and final product testing.
• Develop, maintain, and audit documentation supporting the Quality Management System, including Device History Records, specifications, test records, and release testing data.
• Update and maintain quality procedures, test methods, and instructions. Train others as needed.

Qualifications and Skills:

• Experience in a manufacturing environment, preferably medical devices, with relevant qualifications (e.g., 5 GCSEs including Maths/English).
• Ability to read and analyze drawings, procedures, and standards.
• Effective communication skills, ability to work cross-functionally, and represent the QA department.
• Desirable: experience in the medical device industry, knowledge of ISO 13485 & FDA QSR, City & Guilds 743 or equivalent, statistical knowledge, understanding of GMP, GLP, and quality systems, strong attention to detail, organizational skills, and adaptability.