• C007100 00 06 15b

    Careers

Job Title: Quality Manager
Reporting to: Operations Manager
Salary: Competitive / DOE
CVs & Cover Letters / Enquiries: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Job Summary

Novosound are looking for a highly motivated Quality Manager with prior experience in Engineering, Technology and Industrial sectors including Hazardous Locations and Health & Safety.

Reporting to our Operations Manager you would join a growing team at our development and manufacturing facility in the central belt of Scotland where our next generation ultrasound solutions are being created. Responsibilities would include supporting ongoing development of our ISO9001:2015 & ISO80079-34:2018 Quality Management System, acting as the Responsible Person for Hazardous Locations requirements, and developing quality control/assurance processes for new products including medical devices to ISO 13485:2016. Responsibilities also include managing Health & Safety on-site and continuous improvement of Health & Safety processes. You will have knowledge of the engineering processes & regulatory frameworks utilised in our industry and markets, clear written and verbal skills, and the ability to communicate well across a variety of internal and external parties.

Dimensions

  • Bachelor’s Degree in an engineering or quality control discipline, or equivalent work experience.
  • 3-5 years management with quality, product compliance and Health & Safety experience in Engineering and Industrial sectors including Hazardous Locations.
  • Competent to conduct ATEX Responsible Persons obligations on behalf of the organisation.
  • Able to liaise with suppliers, customers, notified bodies and support our internal product development, engineering and operations teams.
  • Experience of day-to-day Health & Safety tasks such as risk assessments, COSHH assessments and general Health & Safety procedures.
  • Comfortable using a variety of software productivity tools in a paper-free office.
  • Able to create and manage complex project plans & engineering/quality documentation to ensure successful delivery of responsibilities.
  • Able to prioritise and manage conflicting requirements.

 

Key Responsibilities

  • Verifying that novosound products meet all regulatory requirements:
    • Providing guidance to the Development and Engineering Teams regarding product compliance and Technical File requirements
    • Coordinating submission/ongoing maintenance for CE and other country marks
    • Coordinating other industry or market sector approvals
  • Developing and continually improving the Quality Management System, including conducting internal audits
  • Acting as the point of contact with regulatory and other compliance bodies & executing the duties of the ATEX Responsible Person
  • Informing and liaising with relevant Novosound parties on future changes to regulation, key initiatives, and critical issues
  • Driving/proposing continuous improvement ideas on product, documentation, and Health & Safety
  • Providing guidance to the leadership and engineering development teams for any country specific Hazardous Location requirements necessary to support future market opportunities
  • Collaborating with the current Compliance Manager on the following:
    • Engaging with a selected notified body to implement the relevant aspects of ISO 13485:2016 Medical Devices standard to the QMS to enable Novosound to commercialise outcomes from the Dental project
    • Implementing identified requirements to the Dental project to align development records to the standard’s requirements
    • Establishing and managing implementation project plan, budget, and critical dependencies
    • Other tasks related to Compliance succession planning
  • Providing compliance support to any other business compliance aspects that may arise during the course of Novosound’s development
  • Liaising with suppliers and customers on matters regarding product quality requirements and specifications
  • Supporting/developing operations process and product monitoring including the non-conformance process, and supporting the Development/Engineering teams on quality related aspects
  • Ensuring that quality/Health & Safety records are identified and retained in accordance with product requirements
  • Preparing and maintaining Key Performance Indicators
  • Preparing product specific reports, reporting/recording Health & Safety metrics and incidents, final sign off on quality and Health & Safety documentation


*We reserve the right to close this vacancy early should we receive a high volume of applicants. 

© Novosound 2019. Designed & built by Mucky Puddle

We use cookies

We use cookies on our website. Some of them are essential for the operation of the site, while others help us to improve this site and the user experience (tracking cookies). You can decide for yourself whether you want to allow cookies or not. Please note that if you reject them, you may not be able to use all the functionalities of the site.