Quality Controller

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

Job summary

A leading company in innovative tissue-healing technology seeks a QA/QC professional in Bristol. This role involves ensuring product quality through thorough testing and documentation within the medical device industry. Candidates with strong communication skills, relevant qualifications, and a keen eye for detail will thrive here.

Qualifications

• Experience in a manufacturing environment (medical device preferred).
• Familiarity with ISO 13485, FDA QSR, GMP, GxP.
• Ability to interpret drawings, procedures, and standards.

Responsibilities

• Conducting QA/QC functions and reporting non-conformances.
• Product release planning and testing.
• Maintaining documentation for the Quality Management System.

Skills

Strong communication skills

Organizational skills

Attention to detail

Ability to manage time effectively

Education

5 GCSEs or equivalent including Maths and English

QA/QC qualifications

Job description

Social network you want to login/join with:

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, as well as under 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 several countries and sold globally through various channels. The group has R&D hubs in the UK, Ireland, Germany, France, and Israel, and employs over 1,500 staff.

AMS is committed to equal employment opportunities and values diversity across its workforce, prohibiting discrimination based on gender, race, age, nationality, disability, or other protected characteristics.

Role Overview:

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

Key Responsibilities:

• Product release planning, goods receiving inspection, testing, and final product release.
• Developing, maintaining, and auditing documentation supporting the Quality Management System, including Device History Records, Material and Product Specifications, Test Records, and In-process & product release testing.
• Updating and maintaining quality procedures, test methods, and instructions; training others as required.

Qualifications and Skills:

• 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 interpret drawings, procedures, and standards.
• Strong communication skills, organizational skills, and the ability to manage time effectively.
• Knowledge of ISO 13485, FDA QSR, GMP, GxP, and quality techniques.
• Attention to detail, adaptability, and the ability to work in a team environment.