Education/Educacion: BS or BA degree preferred in Materials Engineering or similar engineering professions such as: Industrial Engineering, Mechanical/Electromechanical Engineering, Chemical Engineering.
Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): ISO 13485 leader auditor (Desirable).
Working knowledge of Medical Device Regulations, In Vitro Diagnostic Regulation, cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001 (Desirable).
Negotiation course (Desirable).
Risk management (Desirable).
Validations and root cause analysis (Desirable).
PPAP (Desirable).
Languages ??required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): Advanced English (no less than 90% Oral and written) (required).
Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido: Microsoft Office (required) Internet (required) Email (required) Project, Visio, Mini Tab (desirable) Oracle, Agile (desirable) Qualifications/Cualificaciones: Conflict management Planning Organized Handling ambiguity Decision quality Trust and integrity Summary of Duties and Responsibilities/ Resumen de funciones y responsabilidades: Execute all applicable activities to comply with regulatory standards and meet the requirements stablished in the Quality Management System around supplier's quality management.
Conduct through technical reviews on suppliers to understand their capability to make parts and/or provide services.
Oversee, asses and monitor suppliers as it relates to servicing, manufacturing, process and quality control practices, corrective action, continuous improvement, and "First Article Inspection" (as applicable).
Define and approve PPAP requirement for all new and revised purchased parts (as applicable).
Follow up for their on-time completion.
Work along with the suppliers, to exceed the "fit, form and function" and reliability requirements, while working internally with Research & Development and Design Assurance.
Issue and follow up on Agile Quality figures called "SCARs" and "SACAs" and "NCEs" related to suppliers.
Monitor timing of the workflows to comply with key performance indicators stablished by Hologic, Inc. Work collaboratively with suppliers on problem solving and root cause analysis to avoid repeat failures.
Apply (as applicable), metrology and statistical measurement to problem analysis and resolution.
Work with Post Market Surveillance and other applicable departments (Quality Engineering, MFG Engineering, Research and Development, etc.)
to address complaints linked to supplier situations.
Resolve quality day to day issues associated with suppliers around the globe by addressing non-conformities: call into containment and work along with the corresponding departments to achieve disposition of the impacted raw material (return to supplier, rework, sort, etc.).
If applicable, collect and send back samples to suppliers if needed.
Work with Incoming Quality to include suppliers in the "Skip Lot Program", or remove suppliers out of it, if applicable.
Maintain complete supplier quality records as per the applicable procedures (e.g., supplier performance key indicators, supplier's quality certifications, etc.).
Update suppliers' files when required and check that the information is accurate and complete, assuring that all applicable regulatory standards are met.
Support audits as a subject matter expert.
Travel might be required.
Update the ERP system with the status of the approved suppliers for the different material components and/or services.
As applicable, attend to functional and departmental meetings and follow up on action items accordingly.
If needed, coordinate the change in specifications and/or procedures when required through the corresponding change order.
Train yourself in the respective procedures in the training system, before executing the respective task.
Generate supplier performance metrics to be used in decision making.
Provide the necessary reports to the stakeholders Coordinate Periodic Quality Review meetings with suppliers that require it, as well as follow up on the activities agreed upon in these meetings to ensure that they are carried out.
Coordinate and execute activities related to the implementation of new suppliers as a result of the introduction of new products, transfer of products, alternate suppliers, etc.
; ensuring that the suppliers comply with the requirements stipulated in the quality system before the closure of the projects.
Qualification of new suppliers and/or new parts/components of an already approved supplier.
Perform other duties as required by his/her supervisor/manager.