Our client a leading medical device manufacturing company based Cork requires a Quality Engineer for a contract role.
The Supplier Quality Engineer is mainly responsible for influencing, negotiating, and executing on the Finished Goods Date of Manufacturing program, through creation of baseline IT requirements, onsite travelling to suppliers and execution of collaborated IT interfaces to ensure compliance to a harmonised Date of Manufacture (DoM) approach, whilst using strong quality assurance leadership to manage the companies key Suppliers.
Interface with senior leadership team of the DoM Project team and the Finished Good suppliers. Interfaces including IT, procurement, PMO (Project Management Office) and where required all disciplines across the company's Orthopaedic sites
Main Duties & Responsibilities:
- Point of contact for Global Supply Chain for DoM project.
- Provide leadership to improve the DoM requirement across the Finished Goods Suppliers
- 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.
- Provide technical guidance in developing, negotiating and closing supplier agreements.
- 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.
Key Competencies Required
- 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
- Excellent planning and organisation skills
- Customer & Patient focused
- Holistic thinking
- A minimum of a Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred.
- Minimum 5+ 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 (average 2/month)
- Strong in MRP ERP IT Systems and the labelling requirements
- 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).
- 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
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