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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 and white label. Since 2019, AMS has made seven acquisitions, including Sealantis, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll, and Peters Surgical. AMS's products are manufactured across various countries and sold globally through a network of partners, distributors, and direct sales forces. The group has R&D hubs in the UK, Ireland, Germany, France, and Israel, and has over 1,500 employees since its establishment in 1991. 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 Overview:
The successful candidate will be responsible for conducting all QA/QC functions, prioritizing demands, working according to SOPs and PWIs, and reporting non-conformances or deviations through appropriate channels.
Key Responsibilities:
1. Product release planning, performing goods receiving inspection and testing, in-process inspection and testing, and final product release.
2. Developing, maintaining, and auditing documentation to support an effective and compliant Quality Management System, including Device History Records, Material and Product Specifications, Test Records, and In-process & Product Release Testing.
3. Creating, updating, and maintaining quality procedures, test methods, and instructions, and training others as required.
Qualifications and Skills:
* Grounding in a manufacturing environment (medical device preferred), with previous QC/QA experience and 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 ISO 13485 & FDA QSR requirements, City & Guilds 743 or equivalent, statistical knowledge, understanding of quality techniques and implementation, GMP, GLP, and Quality Systems knowledge.
* Strong attention to detail, good organizational skills, ability to manage time effectively, prioritize tasks, and meet deadlines.
* Good communication skills, both written and verbal, and adaptability to changing environments.
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