Quality Controller

Advanced Medical Solutions; Plymouth; On-site; GBP 25,000 - 35,000; Full time

Job summary

A leading company in innovative tissue-healing technology is seeking a Quality Controller for a 12-month contract. This role will involve conducting QA/QC functions, product testing, and maintaining quality documentation within a dynamic manufacturing environment. The ideal candidate will have experience in the medical device industry, a solid understanding of quality processes, and excellent organizational skills.

Qualifications

• Experience in a manufacturing environment, preferably medical devices.
• Desirable: City & Guilds 743 or equivalent, statistical knowledge.

Responsibilities

• Conducting all QA/QC functions, prioritizing tasks according to demand.
• Product release planning, in-process inspection and testing.
• Maintaining and auditing documentation for Quality Management System.

Skills

Attention to detail

Organizational skills

Effective time management

Excellent communication skills

Ability to read and analyze drawings

Education

At least 5 GCSEs (including Maths and English)

QA/QC qualifications

Tools

Quality Management System knowledge

Knowledge of ISO 13485

Knowledge of FDA QSR requirements

Job description

Quality Controller - 12 month Contract

Who are Advanced Medical Solutions?

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. Established in 1991, AMS employs over 1,500 staff. For more information, visit www.admedsol.com.

AMS is an equal opportunity employer, valuing diversity and ensuring no discrimination based on gender, race, age, nationality, disability, or other protected characteristics.

Job Details

This role involves conducting all QA/QC functions, prioritizing tasks according to demand, working to SOPs and PWIs, and reporting non-conformances or deviations through appropriate channels.

What will this role involve?

• Product release planning, performing goods receiving inspection & testing, in-process inspection and testing, and final product release testing.
• Developing, generating, 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 data.
• Creating, updating, and maintaining quality procedures, test methods, and instructions. Training others as required.

We're looking for?

• Experience in a manufacturing environment (medical device preferred), with QA/QC qualifications and at least 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 QMS knowledge, strong attention to detail, good organizational skills, effective time management, excellent communication skills, and adaptability.