Job Vacancy - Quality Assurance Assistant
Introduction / The Role
JointMedica is a small company in the medical device sector that is designing and developing a number of implantable orthopaedic devices and their associated instrumentation. JointMedica Ltd are looking for a Quality Assurance Assistant to help maintain and develop the quality system that underpins the business. This person will provide quality support to our QA/RA Manager.
Our quality system covers a wide range of disciplines and services which include the design and testing of product, the forming and machining of implantable grade metals and polymers, cleaning and packing operations, terminal sterilization and distribution of both devices and instruments. The devices we manufacture are of high classification, and hence we require rigorous validation of processes, control of corrective/preventive action and post-market surveillance and follow up.
JointMedica is looking for someone to start as soon as possible working 20 hours per week to suit, initially on a 4 month contract.
Ideally you will have experience or understanding of the medical or orthopaedic industry. Knowledge of ISO 13485 or alternative quality management system standards is required, and knowledge of the Medical Device Regulations is desirable. You will be able to conduct internal audits.
You will be expected to help maintain the QMS, and by working with others within the business, improve its efficacy. You will also be able to provide appropriate input during external audits.
External and Internal Auditing
Corrective Action Management
Reviewing and updating Quality System Records
Reviewing Engineering Change Notes
Keeping SOP’s up-to-date
Writing Internal SOP’s and other QMS documents
Keeping Training Records up-to-date
Making sure Customer Complaint Records are completed and closed out
Required Job Skills:
Strong problem-solving skills.
Ability to work with staff at differing levels of the organisation.
Competence to assess and upgrade procedures and systems.
Strong communication skills.
A team player.
Versatile and a self-starter able to work without supervision.
Attention to detail is essential
JointMedica was formed in 2000. We are a small autonomous business designing and manufacturing Orthopaedic Devices, working in friendly cooperation with respected orthopaedic surgeons, experienced engineers, and a variety of cutting-edge manufacturing companies. We specialise in the creation of products that are highly innovative while at the same time meeting the heightened expectations of patients, along with the stringent quality and safety standards that apply to modern orthopaedic implants.
To apply please send your CV and covering letter and state salary expectations to - email@example.com
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Unit 3, Ball Mill Top Business Park