Job Description

We are looking for a forward thinking Quality Assurance Manager that provides leadership of the Quality function to our site in Newport, United Kingdom. This key leadership position is accountable for improving product and process quality. Leading the development, sustaining, and improvement of the quality management system, and managing customer expectations. The person in this position is also responsible to structure and develop the QA team in support of business growth while creating a culture where everyone owns quality.

• Sets 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.
• Provides leadership and coaching to Operations Quality, Quality Systems, and Technical Quality/Quality Engineering teams (5-8 direct reports; total QA team: 10-15 employees).
• Leads, maintains and creates efficiencies in the Quality Management System to fulfill international quality system requirements (e.g. 21 CFR 820, ISO 9001, ISO 13485, and IVDR).
• 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).
• 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.
• Sets 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.

Required Knowledge, Skills, and Abilities

5 years of experience in a Quality management role in an IVDD and ISO 9001 manufacturing environment or ISO 13485 certified medical-device manufacturing company. Extensive 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. Strong, proven leadership, communication, and personnel management skills that inspire and motivate a team. Must have had experience with formal goal and objectives setting. Effective written and oral communication skills in English. 5%-10% travel requirement. Bachelor’s Degree in a relevant subject. 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/molding industry.