Supply Quality Engineer
- Location: NETPark, Sedgefield
- Line Manager: Operations Director
To ensure stable production and supply, product safety, quality and legality, internally and in the supply chain by way of applying necessary procedures and standards, and thereafter continually challenging and improving upon accepted practices, to the benefit of our customers and the company.
- Responsible for the delivery of all aspects of product quality (medical devices).
- Responsible for monitoring and developing production carried out at the contract manufacturing facility.
- To be responsible for developing suppliers using the appropriate quality tools (Process Capability, SPC, FMEA, Error Proofing, 8D and DoE).
- Provide support and assistance to suppliers in development and execution of corrective actions, with strong focus on preventing reoccurrence.
- Perform supplier evaluation and process audits.
- Develop and monitor supplier performance metrics and initiate improvement plans when appropriate.
- Give quality and production input into strategic decisions.
- Be involved in the development, management and monitoring of a fully integrated Quality Management System for a medical devices company.
- To lead/assist in the delivery of successful internal company audits, supplier audits and audits from a notified body on the quality systems to ISO 13485 standards.
- Develop robust Quality Control and validation systems.
- Provide technical knowledge and support to other departments.
- Ensure compliance with ISO 13485 and CE, maintaining the high standards needed for medical device accreditations.
- Challenge and contribute to establishing training standards, ensuring all staff receive appropriate training.
- Communicate technical issues and updates to staff and other team members.
- Be responsible for conducting and overseeing root cause analysis for any reported issues through various quality tools.
- Manage change and continuous improvement through change control systems.
- Oversee and manage the CAPA and NCR system.
- Organise and ensure completion of all product testing.
- Ensure customer complaints are appropriately recorded and actioned in real time.
- Report defined QA metrics into management.
- Assist with registration of medical devices into other countries when needed.
- Support new product development, validation, regulatory approvals, and launch.
- Continuous Improvement: Constantly measures for the effectiveness of processes and strives to meet more difficult objectives. Generates new ideas and manages change effectively.
- Collaborative Skills: Initiates and develops relationships, and gains the confidence and cooperation of people within and outside the business.
- Results Focus/Execution: A results oriented employee who sets challenging goals and achieves results, whilst prioritizing tasks and overcoming obstacles.
- Communication Skills: Excellent written and verbal communication skills with the ability to present ideas and information clearly at all levels. Has the ability to adapt style, and listens to and values different opinions.
- Problem Solving/Decision Making: Evaluates, generates, and implements problem-solving solutions. Has the ability to analyse situations systematically and make effective decisions.
- Planning & Organising: Develops realistic work plans, sets goals, and aligns personal plans/goals with company goals. Manages time well and effectively, including personal attendance and on-time performance
- Qualifications in a related subject or able to demonstrate a proven track record with relevant experience.
- Relevant experience in a supply quality, engineering, product engineering or other similar role.
- Relevant experience in Electronics and Mechanical device design, development, product engineering and supply chain experience.
- In depth knowledge of quality systems and standards (preferably ISO13485)
- Ability to communicate effectively in both written and oral at all levels within the organisation.
- Ability to travel at short notice to visit suppliers, some travel may be international
- Must be a motivated self-starter
- Significant experience in a Supplier Quality Assurance role
- Previous experience of working in the medical device sector
- Experience of people managing, leading and developing a team
How to Apply
To apply for this position please email firstname.lastname@example.org with a copy of your CV and a cover letter explaining what interests you to this role and why you feel you are suitable. Please note only candidates selected for interview will be contacted.
A full job description will be available for candidates who are selected for interview.
Please note that all short listed candidates will be expected to demonstrate at the time of interview their legal right to live and work in the UK by presentation of appropriate original documents. General guidance can be found at the UK Border Agency’s website: www.bia.homeoffice.gov.uk