Education/Educación:
- BS or BA degree in Chemical, Materials Engineering or Industrial Engineering
Specialized Knowledge/ Conocimiento especializado:
- ISO 13485 leader auditor
- Working knowledge of Medical Device Regulations, In Vitro Diagnostic Regulation, cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001
- Negotiation course
- Risk management
- Validations and root cause analysis
- PPAP
Languages required for the position / Idiomas requeridos para el puesto:
- Advanced English (Level B2 and above, oral and written).
Computer tools and knowledge level / Herramientas informáticas y nível de conocimiento requerido:
- Microsoft Office (required)
- Project, Visio, Mini Tab (Desirable)
- Oracle, Agile (Desirable)
Qualifications/Cualificaciones:
- Conflict management
- Planning
- Organized
- Handling ambiguity
- Quality decision making
- Trust and integrity
Summary of Duties and Responsibilities/ Resumen de funciones y responsabilidades:
The following list is focused only on chemical, biological, and packaging raw material supplier activities impacting quality:
- Execute all applicable activities to comply with regulatory standards and meet the requirements established in the Quality Management System around supplier's quality management.
- Conduct thorough technical reviews on suppliers to understand their capability to make materials.
- Oversee, assess, 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 requirements 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 ("SCARs", "SACAs", and/or "NCEs") related to suppliers.
Monitor timing of the workflows to comply with key performance indicators established by Hologic, Inc.
- Work with Post Market Surveillance and other applicable departments (Quality Engineering, MFG Engineering, Research & Development, etc.)
to address complaints linked to supplier challenges.
- Resolve day-to-day quality challenges 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 add or remove suppliers from the "Skip Lot" Program, as applicable.
- Maintain supplier quality records, per the applicable procedures (e.g., supplier performance key indicators, supplier's quality certifications, etc.).
Update supplier files when required and verify the information is accurate and complete, assuring that all applicable regulatory standards are met.
- Update the ERP system with the status of the approved suppliers for the different raw 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 because of new product(s) introduction, transfer of product(s), 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 raw materials/components of an existing approved supplier.
- Perform other duties as required by his/her supervisor/manager.