Senior Quality Engineer NPI

• Lead and effectively deliver all quality related aspects of New Product Introduction, ensuring all customer requirements are identified, documented, understood and met.
• Be part of project teams. Deliver on commits to schedule and budget.
• Work with customers and suppliers on quality related issues and new product introduction projects. Ensure all dealings are professional and good relationships are always maintained.
• Ensure processes are validated in accordance with customer and the Quality System requirements. Write validation protocols, reports and test reports as required.
• Ensure that all customer requirements are identified, clearly documented in the manufacturing documentation and effectively implemented.
• Assess all product and manufacturing related changes, deviations and reworks, for their impact on validations, product quality and customer requirements.
• Lead and investigate product/process quality issues that arise, including customer complaints. Ensure they are effectively resolved in a timely manner using the CAPA system.
• Ensure the Quality System is fully compliant with customer and regulatory requirements.
• Lead the implementation of Structured Problem Solving to drive root cause identification for process and product issues.
• Drive and implement continuous improvement to processes and product quality.
• Perform an active role in further development of the quality management system.
• Supervision, coaching and mentoring of Quality Technicians and Quality Engineers.
• Work with suppliers and customers on the resolution of product quality issues and quality improvement programs.
• To take on other duties which the Company may assign you from time to time.
• Keep your skills current and be conversant with the latest developments which are relevant to the Company's business.

• Bachelor's degree in Science, Engineering, Manufacturing or related field.
• Thorough knowledge of medical devices quality systems (ISO13485/FDA).
• A minimum of five years of relevant progressive experience within a similar environment role.
• Experience of New Product Introduction and manufacturing process transfer.
• Strong Structured Problem Solving and Root Cause Analysis experience (Lean 6 Sigma Green Belt desirable).
• Strong leadership and people management skills.
• Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.).
• Must be able to communicate at all levels of the organisation and with customers, suppliers and regulatory agencies.
• Good interpersonal skills, team player, with a positive attitude in dealing with people.
• Must be innovative and be driven to implement change to systems and procedures.
• Excellent analytical skills. Ability to define problems, collect data, establish facts, and draw conclusions.
• Demonstrable ability to achieve goals through collaborating, influencing and interaction at all levels across the business/function.

Collins McNicholas