The Senior Supplier Quality Engineer is mainly responsible for leading current project compliancy requirements and project completions. The project teams will require influencing, supporting, and monitoring to ensure targets are met and communicate to the LT (Leadership team).
- Point of contact for Global Supply Chain for a supplier labelling compliancy project.
- Point of contact for supplier agreements project.
- Provide leadership to improve present project structures
- Influence the Senior Leadership teams of the ASL to ensure strategic focus on completing supplier harmonisation
- Liaise with internal stakeholders to ensure that supplier agreements are adequately assessed and deployed.
- Provide technical guidance in developing, negotiating and closing supplier agreements
- Provide technical guidance in developing, negotiating and supplier labelling solutions.
- Lead the resolution of problems & eliminate constraints to ensure project targets are met.
- 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.
- Know and follow all laws and policies that apply to one’s job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Excellent Communication & Negotiation Skills
- Influencing skills in an international matrix environment
- Pro-active approach to work with hands on ability
- Team Player
- Highly computer literate
- GMP knowledge
- Excellent project management skills
- Attention to detail
- High work standards
- Holistic thinking
- Excellent planning and organisation skills
- Customer & Patient focused
- 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 ISO 13485 knowledge is preferred
- Negotiation skills
- Knowledge in international contract management
- Willingness to travel
- Strong in Regulations, agreements, labelling, MRP ERP IT Systems
- Strong communication, teamwork, and problem-solving skills are required.
- Experienced Lead for agreement and labelling projects or similar
- Process Excellence – Green/Black belt certification
- ISO 9001 Internal/External Auditor or ASQ Certification as an Auditor.
- Project management experience.
- Knowledge of Orthopaedic products, tools and manufacturing processes
For a confidential discussion and more information on the role, please contact Eloisa Ruiz on 021 4809118 or email email@example.com