Quality Assurance Supervisor
Provide Quality Management support cross functional support within the product development and manufacturing environments to ensure the company's products are designed, developed and manufactured to exceptional quality standards. Improve the quality systems and quality processes within the company to enable strategic business objectives and goals to be achieved.
Support and improve the design processes in product development and manufacturing.
Ensure that the development of the company's products complies with FDA, MDD, ISO 13485 and other medical device regulations.
Ensure that technical documentation adheres to approved processes and complies with the relevant regulations.
Support Technical and Design Reviews from a quality engineering perspective.
Create and manage Design History Files and documentation roadmaps.
Train engineering groups in the quality processes
Develop the CAPA and Non-conformance reporting process.
Develop the complaints handling, issue, documentation and statistical reporting management systems.
Develop the Internal Audit Program and support Notified Body Audit/External Audits.
Introduce an NPI process for design and operations collaboration.
Suggest and support improvements of the QMS.
Manage and coordinate the weekly input to the KPI process, to ensure objectives are met.
Provide ongoing support for change control activities.
Daily support for all activities that feed into the centralised approach for the QMS.
Champion a quality and continuous improvement culture within the company.
Undertake any other specific tasks as detailed by manager.
Ensure own compliance with health and safety regulations
Be proactive in own personal continuous professional development.
Degree (or equivalent) related subject area with Quality Management experience in Food Manufacturing/Medical Device and/or Biopharmaceutical environment.
Experience in the Medical Device industry or similar regulated industries.
Experience with Quality Management Systems.
Experience with Quality System Audits.
Knowledge of Product Development lifecycles.
Knowledge of Testing Strategies, Verification and Validation.
Knowledge of Project Management, Lean, Six-Sigma and 5S methodologies.
Knowledge of relevant international standards, regulations and guidelines (EU Directives, MEDDEV guidelines, FDA regulatory standards, FDA 510(k), ISO 13485).
Very good oral, written, cross functional and interpersonal communication skills that are appropriate for various levels, including other departments and external stakeholders.
Able to work independently and as part of a team showing good inter-personal and information transfer skills.
Analytical and problem-solving approach.
Project and results oriented.
IT: Versatile with Microsoft Office (Word, Excel, PowerPoint, Project).
Demonstrate a positive attitude to change and contribute to new ideas and improved ways of working.
Looks beyond boundaries of own job to support others.
Demonstrate sound work of ethics