Supplier Quality Engineer

• 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 Electronics/ Metal suppliers to understand their capability to make Electronics/ Metal 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 for their on-time completion.
• Work along with Electronics / Metal 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”, “SACAs”, and “NCEs” related to suppliers providing components. Monitor timing of the workflows to comply with key performance indicators established by Hologic, Inc.
• Work collaboratively with Electronics/Metal 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 Electronics /Metal situations.
• 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 procedure (e.g., supplier performance key indicators, supplier's quality certifications, etc.). Update Electronics/ Metal 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 Electronics /Metal 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.
• 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 Electronics /Metal 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 Electronics /Metal suppliers as a result of the introduction of new products, transfer of products, alternate suppliers, etc.; ensuring that the component's 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.

• Communication-must be able to effectively communicate in both written and verbal forms, and at all levels in the organization.
• Working knowledge of Medical Device Regulations, In Vitro Diagnostic Regulation, cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001 (Desirable).
• Knowledge of project management techniques.
• 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.
• Must be able to work independently and with all levels of the organization.
• 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.
• ISO 13485 leader auditor (Desirable).
• Quality System Regulation (Desirable).
• Negotiation course (Desirable).
• Risk management (Desirable).
• Validations and root cause analysis (Desirable).
• PPAP (Desirable).
• Proficiency with Agile and Oracle (Desirable).
• Must follow all applicable FDA regulations

• Bachelor's degree preferred in Materials/Electronic/Electric Engineering or any other Bachelor-related Engineering career.
• For the Technical Certification/University Diploma, a minimum of 10 years of experience in positions of similar nature is required.
• ASQ Supplier Quality Engineer Certificate (Desirable).
• 2 or more years of experience in Quality Assurance of material manufacturing technology (for example: Electronics, Metals)
• 2 or more years of experience in medical device manufacturing or related industry.
• Technical knowledge in Electronics/Metals processes, such as printed circuit board assemblies, cables, machined parts, etc. (Desirable).
• Full clean driver's license.

Hologic