Quality Specialist

Job Description Summary

Here at BD, we have an exciting opportunity for a Quality Specialist to join our Home care division. This position will be based between three sites: Winnersh, Crawley and West Worthing, you can based at either location, however, will need to attend the Worthing site on a weekly basis.

In this role you will manage and maintain the Quality Management System. Ensuring compliance to all Local, Regional and Corporate processes and procedures driving continual improvements.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

• Manage and maintain local Quality Management System processes and procedures.
• In collaboration with the Quality Manager, develop the Quality Management System, provide support and contribute to the business strategy and programs.
• Responsible for the continual improvement of Quality System documents including writing procedures, work instructions and forms/templates in collaboration with departments and ensure adherence to them.
• Co-ordinate and support audits with reviewing schedules, audit plans and reports, leading and participating where applicable, communicating findings to the appropriate personnel and working to ensure the timely closure of actions. Audits include internal, corporate and external ISO certification audits.
• Drive simplification within the QMS and harmonise best practices.
• Perform local quality activities in the warehouse.
• Coordinate Document Change Management activities for local changes.
• Implement BDX Corporate and regional procedures and processes including Quality Management System reviews, as appropriate; implement and maintain processes required to support the business.
• Support Management Review process; by preparing, interpreting and concluding on the reported data.
• Complete non-conformances and CAPAs in a timely manner, compliant with applicable procedures.
• Develop and maintain strong relationships with internal and external stakeholders to drive improvements.
• Management of training to local associates and follow-up to ensure timely completion, in order to adhere to established quality and regulatory requirements.
• Responsible for ensuring that quality holds have been communicated and enacted on.

• BSc degree in a relevant subject is a distinct advantage.
• 3-5 years working in a Quality Assurance or Regulatory role in a medical device/pharmaceutical organisation. Experience from other backgrounds other than Medical will be considered
• Experience collaborating with all levels of management to drive improvements.
• Customer centric focused.
• Good working knowledge of Quality Management System requirements, in particular ISO 9001, or 13485
• Strong relationship building skills; demonstrated leadership coupled with the ability to work well with people at all levels and in all functions of the organisation as well as with external regulatory agencies.
• Good analytical skills; attention to detail and ability to handle multiple tasks and priorities at the same time.
• Excellent communications, technical and presentation skills.
• Computer skills (Advanced with Microsoft Excel, Word, Outlook and PowerPoint).