Enable job alerts via email!

Quality Controller

Advanced Medical Solutions

Plymouth

On-site

GBP 25,000 - 35,000

Full time

30+ days ago

Generate a tailored resume in minutes

Land an interview and earn more. Learn more

Job summary

A leading medical device manufacturer in Plymouth is seeking a Quality Assurance Associate to perform inspections and maintain compliance within the Quality Management System. The ideal candidate will have a background in manufacturing and previous QC/QA experience, ensuring that Good Manufacturing Practices are upheld. This full-time role offers an opportunity to contribute to quality outcomes in healthcare technology.

Qualifications

Prior QC/QA experience in a manufacturing environment, preferably medical devices.
Ability to read and understand drawings, procedures, and standards.
Knowledge of Good Manufacturing Practice and Quality Systems.

Responsibilities

Conduct all QA/QC related functions and prioritization.
Maintain documentation for a compliant Quality Management System.
Perform inspections and testing during product release.

Skills

Attention to detail

Organisational skills

Communication skills

Analytical skills

Knowledge of ISO13485

Education

5 GCSEs including Maths/English

City & Guilds 743 or equivalent

Tools

Quality Management Systems

Overview

Head of Global Recruitment at Advanced Medical Solutions

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, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see www.admedsol.com

AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.

Role and responsibilities

Reporting to the Quality Manager you will be responsible for conducting all QA/ QC related functions, and prioritisation in relation to demands. Working to SOPs and PWIs, reporting any non-conformances or deviations as they arise through the appropriate channels.

Product Release.
Planning / performing Goods Receiving inspection & testing.
In-process inspection and testing, and testing for final product release.
Any other reasonable requirement as required to meet the business objectives.

What will this role involve?

Develop, generate, maintain and audit documentation to support an effective and compliant Quality Management System, including:

Device History records.
Material and Product Specifications.
Test records.
In- process & product release testing, accurately recording data, calculation of results.
Generate, update and maintain Quality procedures, test methods, instructions.
To train others as required.
Ensuring that Good Manufacturing Practice (GMP) is maintained at all times.
Prevention of product, process and Quality Management System non-conformances.
Compliance with approved procedures.
Stringency in following Quality Management System and Health & Safety requirements.
Generate and review results of testing activities against specified acceptance criteria.
Consult with the QM should any test result fail to meet acceptance criteria or anticipated result.
Comply with Out of Specification (OOS) test results, Non-conformance and CAPA procedures.
Determine priorities at the start of, and throughout, each shift.
Work closely with Quality, Manufacturing, Supply Chain, and R&D departments.
Be prepared to work at any AMS site as required by the QM.
Be prepared to work on project teams as required.
Communicate clearly, both verbally & in writing with their immediate team, other departments and with external Customers & Suppliers.

What we’re looking for

A background in a manufacturing environment (medical device preferred), previous QC/QA experience, with appropriate qualifications of 5 GCSE’s or equivalent including Maths/English.
Ability to read, analyse, and understand drawings / procedures / standards.
Ability to represent the department in cross-functional interactions.
Experience in medical device industry / Knowledge of ISO13485 & FDA QSR requirements.
City & Guilds 743 or equivalent.
Statistical knowledge.
Knowledge of world class quality techniques and implementation.
Knowledge of Good Manufacturing Practice, Good Laboratory Practice and Quality Systems.
Strong attention to detail.
Good organisational skills.
Able to manage own time effectively, prioritise tasks and deliver to critical deadlines.
Good communication skills; written, verbal and presenting.
Flexible and adaptable to changing work environment.

Advanced Medical Solutions Group PLC engages recruitment services strictly through executed written agreements. Any unsolicited resumes, candidate profiles, or referrals submitted by agencies or search firms in the absence of such an agreement shall be deemed the property of Advanced Medical Solutions Group PLC. No remuneration or placement fee will be recognized or paid under these circumstances.

Location and seniority