Jointmedica Limited, Worcester, UK    |    +44 (0) 1905 640008    |    cs@jointmedica.com   |   Privacy Policy   |   Disclaimer

© 2019 Jointmedica Limited all rights reserved

  • Facebook - White Circle
  • LinkedIn - White Circle
  • Twitter - White Circle
  • Instagram - White Circle

Job Vacancy - Quality System Engineer

Introduction / The Role

Jointmedica is a small company in the Medical device sector that is designing, developing and marketing a number of implantable orthopaedic devices and their associated instrumentation. Whilst the company according to its registration is the legal manufacturer of the devices, it makes use of the subcontract services of a number of providers in order to complete its product. Jointmedica Ltd are looking for an experienced Quality Engineer to maintain and develop the quality system that underpins the business. This person will provide quality support working on projects under the guidance of the Technical Director and external consultants.

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.

Key requirements

Ideally you will have experience or understanding of the standards expected in the high classification Medical Device arena. Familiarity within the orthopaedic industry would be an advantage. Knowledge of ISO9001 is expected.  Knowledge of ISO13485 is desirable. You will have an engineering qualification, served apprenticeship or equivalent.

You will be expected to maintain the QMS, and by working with others within the business, improve its efficacy. You will also be able to provide appropriate input during Audit.

You will have a practical understanding of a number of areas: The writing of SOP’s and other quality system documentation, the requirements of the Technical files, Validation and process control.

 

Job Responsibilities:

  • External and Internal Auditing

  • Create and manage Design history file

  • Corrective Action Management

  • Liaise with sub contractors and manufacturing controls

  • Establishing working methods and documentation.

  • Reviewing and updating Quality System Records

  • Reviewing Internal Audit Reports and ECN’s

  • Keeping SOP’s and Technical Files up-to-date

  • Writing Internal Process SOP’s

  • 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 details is essential
     

About Jointmedica Ltd

Jointmedica was formed in 2008. We are a small autonomous business 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.

 

Please apply in writing, to include your CV and covering letter and state salary expectations to:-

Jointmedica Ltd

Unit 3, Ball Mill Top Business Park

Main Road

Hallow

Worcestershire

WR2 6LS

 

Or e-mail to:-  cs@jointmedica.com