About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About this role

Support the Supplier Quality organization dedicated to the oversight of components, other materials & services.

What You'll Do

• Conduct technical reviews of suppliers to understand their capability to make materials.
• Monitor suppliers making parts as it relates to manufacturing, process and quality control practices, corrective action, continuous improvement, and “First Article Inspection”.
• Support the definition and approval of 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 “SCARs”, “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.
• Support day-to-day issues associated with suppliers in Costa Rica by addressing nonconformities: 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 supplier audits, as needed.
• 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, support the change in specifications and/or procedures when required through the corresponding change order.
• 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.
• Support 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.
• Support the qualification of new suppliers and/or new parts/components of an already approved supplier.
• Prepare and maintain a Project Tracker with weekly updates for Management Review.
• Knowledge transfer to client during and at completion of the project.
• Other tasks as agreed upon between the Liaisons listed in this Statement of Work.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

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