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 the company
• 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 meet Quality requirements about 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