Our client a global medical device manufacturing company are looking for a Quality Assurance Manager to join their manufacturing facility where you will do important work implementing Quality plans for life saving medical devices.
This Quality Assurance Manager is a leadership role for the Quality function and is accountable for improving product and process quality. Leading the development, sustaining, and improvement of the quality management system, and managing customer expectations.
The Quality Assurance Manager in this position is also responsible to structure and develop the Quality Assurance team in support of business growth while creating a culture where everyone owns quality.
- The Quality Assurance Manager will set the overall quality strategy for the Newport manufacturing site that supports growth and compliance readiness.
- Actively participates in quality improvement projects to move the organization to rely less on inspections and more on quality assurance.
- Carries out leadership responsibilities in accordance with the organization's policies and applicable laws.
- Responsibilities include interviewing, hiring, developing and training employees; planning, assigning, and directing work; appraising performance; rewarding, discipline of employees; addressing complaints and resolving problems.
- The Quality Assurance Manager will provide leadership and coaching to Operations Quality, Quality Systems, and Technical Quality/Quality Engineering teams
- Leads, maintains and creates efficiencies in the Quality Management System to fulfil international quality system requirements (e.g. 21 CFR 820, ISO 9001, ISO 13485, and IVDR etc).
- Assures management reviews of the Quality System are held and properly documented to reflect the status of the Quality System effectiveness and resulting corrective actions and improvement plans/actions.
- Works closely with all staff to ensure that all aspects of the QMS is understood, implemented and maintained.
- Creates cross functional collaboration and influences all business functions to apply appropriate quality tools including Lean, Six Sigma, TQM principles, business process improvement methods and statistical methods (e.g. design of experiments, statistical process control).
- The Quality Assurance Manager maintains alliance with Divisional, Group, and corporate Quality and Regulatory Affairs to ensure participation in and understanding of associated initiatives.
- Effectively manages Corrective and Preventive Action System. Works with various departments to identify actions required to assure corrective and preventative actions are properly documented and follows up to initiate and monitor timely completion of actions.
- Oversees the Internal Audit program assuring compliance with regulatory standards. Coordinate and participate in any external or customer audits.
- The Quality Assurance Manager wilL set site wide QA/QC priorities and key objectives to reduce the cost of poor quality and improve the compliance to regulations and the site Quality System.
- Manages Key Quality Business Metrics and Department Metrics.
- Acts as the site Quality Representative with third party agencies, regulatory agencies and any government agency.
- Other duties may be assigned, as required.
- Experience in a Quality management role in an ISO 13485 certified medical-device manufacturing company ideally - ISO 9001 considered.
- Management experience in a high volume manufacturing environment.
- Experience with problem-solving techniques such as PPI, 8D, DMAIC, PPS.
- Experience with FMEA and other risk management tools.
- Proven leadership, communication, and personnel management skills that inspire and motivate a team.
- 5%-10% travel requirement.
Education and training
- Bachelor's Degree/HND/HNC in a relevant subject or equivalent proven record in a quality role
- MS Office (Word, Excel, Access and PowerPoint) intermediate level.
- Statistical software and/or databases.
- ASQ Quality Engineer or Certified Quality Manager; ASQ lead auditor training 3rd-party training record on ISO 13485 and risk management (ISO 14971)
- Experience with Lean or Six Sigma improvement systems
- Experience in high volume plastics/moulding industry.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales