Sr. Supplier Quality Engineer CR

Education / EducacióN:

• Advanced English proficiency (spoken and written) is required for effective communication in professional and technical contexts.
• Bachelor’s degree from a university in an Engineering field. Desirable (Electronics or Mechatronics) : Master's / Ph.D.

Experience / Experiencia:

• Required: Minimum of 5 years of professional experience, with a bachelor’s degree, in positions with a similar level of responsibility, decision-making and problem solving. Recognized expertise within a similar organization.

Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): 

• Microsoft Office                                                                                     
• Project, Visio, Mini Tab
• Agile: Yes (desirable)   

Qualifications / Cualificaciones:

• Communication—must be able to effectively communicate in both written and verbal forms, and at all levels in the organization.
• Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes.
• Ability to analyze a situation or data; evaluate relevant identifiable factors and translate this information into a meaningful proposal or action plan.
• Ability to effectively communicate ideas and approaches in the form of proposals, plans and presentations.
• High proficiency with Microsoft Office suite to produce reports, analyze data, etc. effectively. 
• Ability to handle and manage multiple complex projects.
• Working knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation (as applicable), cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001.
• Ability to handle and manage multiple complex projects.
• Must be able to work independently and with all levels of the organization.
• ISO 13485 leader auditor.
• Quality System Regulation.
• Risk management.
• Validations (IQ, OQ, PQ) and root cause analysis (CAPA process).
• Knowledge of project management techniques.
• Measurement system analysis (GR&R, AAA).
• Statistical Process Controls (SPC) and statistical sampling know how.
• PPAP (Desirable).
• Must be able to follow applicable regulations (e.g. FDA, Canada, Brazil, Japan, etc.)

Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:

Note: The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs. 

• 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 technical reviews of suppliers to understand their capability to make materials.
• Oversee, assess, and monitor suppliers making parts as it relates to manufacturing, process and quality control practices, corrective action, continuous improvement, and “First Article Inspection”.
• Define and approve PPAP (Production Part Approval Process) requirements for all new and revised purchased parts (as applicable). Follow up on their on-time completion.
• Work along with 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 established by Hologic.
• 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, R&D, etc.) to address complaints linked to supplier situations.
• Resolve 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 material (return to supplier, rework, sort, etc.).   As applicable, collect and send back samples to suppliers if needed.
• As a resolve of a PPAP certified part number, work with Incoming Quality to include suppliers in the “Skip Lot Program” (as applicable) or remove suppliers out of it if poor quality is detected.
• Maintain complete supplier quality records as per the applicable procedure (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, domestic and international.
• Update the ERP system with the status of the approved suppliers for the different materials (as applicable).
• Attend functional and departmental meetings and follow up on action items accordingly.
• If needed, coordinate/ execute the change in specifications and/or procedures when required through the corresponding change order.
• Get trained  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.
• As applicable, participate in periodic supplier review meetings, 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 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.
• Travel requirement: Must be willing to travel up to 50% of the time.