Quality Controller
Posted 1 week ago by Advanced Medical Solutions
Negotiable
Undetermined
Undetermined
Plymouth, England, United Kingdom
Summary: The Quality Controller role at Advanced Medical Solutions involves overseeing all QA/QC functions within a manufacturing environment, particularly in the medical device sector. The position requires adherence to standard operating procedures and the management of documentation to ensure compliance with quality management systems. The successful candidate will also be responsible for product release inspections and training others as needed. This is a 12-month contract position based in Plymouth, England.
Key Responsibilities:
- Conduct all QA/QC related functions and prioritize tasks based on demands.
- Perform product release, goods receiving inspection, and in-process testing.
- Report non-conformances or deviations through appropriate channels.
- Develop, maintain, and audit documentation for a compliant Quality Management System.
- Generate and update quality procedures, test methods, and instructions.
- Train others as required to meet business objectives.
Key Skills:
- Background in a manufacturing environment, preferably medical devices.
- Previous QC/QA experience with qualifications of 5 GCSEs or equivalent including Maths/English.
- Ability to read and understand drawings, procedures, and standards.
- Desirable experience in the medical device industry and knowledge of ISO13485 & FDA QSR requirements.
- Statistical knowledge and understanding of world-class quality techniques.
- Strong attention to detail and good organizational skills.
- Able to manage time effectively and prioritize tasks.
- Good communication skills, both written and verbal.
- Flexible and adaptable to changing work environments.
Salary (Rate): undetermined
City: Plymouth
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. 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.
Job Details
Responsible for conducting all QA/ QC related functions, and prioritisation in relation to demands. Working to SOP’s and PWI’s, reporting any non-conformances or deviations as they arise through the appropriate channels.
What will this role involve?
- 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.
- 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.
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, analyze, and understand drawings / procedures / standards.
- Ability to represent the department in cross-functional interactions.
- Desirable: 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.