MBA qualified results orientated operations, production, quality and engineering manager with over 20 years experience managing teams of engineers, technicians and operators in regulated (ISO13485, FDA CFR Part 820, ISO9001, ISO14001), highly automated and clean room manufacturing GMP environments. Proven ability to work collaboratively with key stakeholders from production, quality, engineering, supply chain and business functions to achieve business goals through the effective leadership and development of team members.Specialties:• Operations management under ISO 13485/9001/14001 & FDA CFR Part 820 regulatory requirements• Certified ISO 13485/9001/14001 Internal Auditor• Quality Engineering for the Medical Device Sector• New product introduction (NPI) leader and engineering support for Medical and Electronic products• Analytical approach to problem solving using methodologies such as corrective and preventive action (CAPA)• Management & reporting of key performance metrics to support and drive business objectives• Use of continuous improvement initiatives to drive staff, production and equipment performance• Start-up/New Facility project management including systems and process design, facility layout design, equipment installation and qualification, process validation, customer audit and sign-off, staff recruitment and training• Staff development including the mentoring of new-hire managers and supervisors