Requirements;
• A minimum of a Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred.
• Minimum 5-6 years’ experience in a Quality or Engineering Function within a Medical Device Company.
• Experience in the medical device, biotech and/or pharmaceutical industry is preferred. Both, FDA and ISO (International Organization for Standardization) regulations knowledge is required FDA CFR Part 820 and/or ISO 13485 knowledge is preferred
• Previous experience of product transfers/start up desired
• Willingness to travel
• Strong in root cause analysis skills
• Strong communication, teamwork, and problem solving skills
• Auditing background is preferred.
• Strong communication, teamwork, and problem solving skills are required.
• Possess knowledge of statistical analysis tools (Minitab SAS preferred).
DESIRABLE:
• 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.
• Project management experience.
• Knowledge of Orthopaedic products and manufacturing processes
KEY COMPETENCIES REQUIRED
• Excellent Communication Skills
• Pro-active approach to work with hands on ability
• Ability to interpret, communicates, and works from drawings and specifications
• Team Player
• Flexible
• Influencing skills
• Validation knowledge
• Highly computer literate
• GMP knowledge
• Excellent project management skills
• Attention to detail
• High work standards
• Excellent planning and organization skills
• Customer focused
JOB TITLE: SUPPLIER QUALITY ENGINEER
DEPARTMENT: GLOBAL SUPPLY CHAIN QUALITY
REPORTS TO: Supplier Quality Manager, EU Direct Material.
JOB PURPOSE:
The Supplier Quality Engineer is responsible for providing quality assurance leadership in the management of External Manufacturers.
ORGANISATIONAL INTERFACES:
All Disciplines within the Manufacturing Facility, Outside suppliers and QA related equipment suppliers, and staff across DePuy Orthopedic sites & J & J companies.
MAIN DUTIES & RESPONSIBILITIES:
 Provide Quality point of contact for Global Supply Chain with External Manufacturers.
 Provide Quality Leadership in support of External Manufacturing Outsourcing programs
 Ensure External Manufacturers continue to meet DePuy Quality requirements with regard to Supplier Change Request process
 Facilitate the completion of the quarterly Suppler Management Committee meeting
 Develop supplier capability in risk assessment such as PFMEA
 Actively support all defined External Manufacturing Quality Systems goals and objectives.
 Represent Quality at Supplier Business Review Meetings
 Conduct on-site quality and process assessments at EM suppliers both to approve new suppliers and on and ongoing 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)
 Resolve problems & eliminate constraints to ensure project and supply targets are met.
• 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.
Jordan
0799936279