Responsible for providing quality assurance leadership for external operations MAIN DUTIES & RESPONSIBILITIES: • Provide Quality point of contact for Global Supply Chain with select Preferred Suppliers and EMs • Provide Quality Leadership in support of External Manufacturing Outsourcing programs • Work at select Preferred Supplier and EM locations to • Produce advanced quality planning documentation • Conduct Process Capability Studies, • Drive cost improvement with the use of PE tools • Develop and manage First Article Inspections as required at suppliers or within DePuy • Develop supplier capability in risk assessment such as PFMEA • Manage training and certification of operators and inspectors to CTQs with the suppliers as required • Develop and implement efficient and effective inspection points and control plans at the supplier that will provide STS status • Actively support all defined External Manufacturing Quality Systems goals and objectives. • Represent Quality at commodity team Supplier Business Review Meetings • Conduct on-site quality and process assessments at preferred and EM suppliers both to approve new suppliers and on an on going basis • Promote continuous improvement and Process Excellence activities within the Global Supply Chain • Review and approve Validation of new/changed production processes as required • Design and validate Quality System processes where appropriate (CSV and Inspection Process) • Participates in design evaluations where appropriate • Resolve problems & eliminate constraints to ensure project and supply targets are met. • Ensure suppliers continue to met DePuy Quality requirements with regard to SEP-619 compliance • Generate Quality metrics on supplier performance and establish measures to monitor quality costs and cost avoidance • Communicate and assure appropriate implementation of Quality Process Specifications (QPS), Quality Control Test Specifications (QCTS), and Raw Material Specifications (RMS) etc. • Ensure effective and timely closure on all Supplier Corrective Action Requests. • Maintain standards of housekeeping & GMP requirements • Represent the Supply Process Quality Assurance function as required by management • Ensure that all Health, Safety and Environmental requirements are fulfilled KEY COMPETENCIES REQUIRED • Excellent Communication Skills • Pro-active approach to work with hands on ability • Ability to interpret, communicate, and work from drawings and specifications • Team Player • Flexible • Influencing skills • High level of validation knowledge • Highly computer literate • High level of GMP knowledge • Excellent project management skills • High attention to detail • High work standards • Excellent planning and organisation skills • Customer focused QUALIFICATIONS & EXPERIENCE • Third level engineering qualification (Certificate Level, College Degree, or Equivalent) preferably in a mechanical or quality discipline. • Experience in a Quality or Engineering Function within a Medical Device / Pharmaceutical Company. • Knowledge of applicable production processes • Previous experience of product transfers/start up • Willingness to travel • Strong in root cause analysis skills • Strong communication, teamwork, and problem solving skills • Demonstrated ability to lead improvement projects with suppliers • Process Excellence – Green/Black belt certification • ISO 9001 Internal/External Auditor or ASQ Certification as an Auditor. • Experienced in SPC, Product Validation and ISO 13485. • Previous People management experience • Project management experience. • Knowledge of Orthopaedic products and manufacturing processes