Supplier Quality Engineer CR; Temporary

Job Description

Advanced English proficiency (oral and written) for professional and technical communication.

University degree in Engineering (Chemical, industrial, materials, mechatronics, electronics or related field).

ASQ Certified Supplier Quality Engineer is a plus.

No prior experience required, although it is desirable to have completed internships in the medical device industry.

• Communication: Ability to communicate effectively, both written and verbal, at all levels of the organization.
• Problem-solving tools: Use of SPC, TQM, etc., to optimize processes.
• Analysis: Ability to analyze situations or data and translate them into proposals or action plans.
• Microsoft Office: High proficiency to generate reports and analyze data.
• Complex project management: Ability to manage multiple complex projects.
• ISO 13485 Lead Auditor: Desirable.
• Quality System Regulation: Desirable.
• Risk Management: Desirable.
• Validations (IQ, OQ, PQ) and root cause analysis (CAPA process): Desirable.
• Project management techniques: Desirable

• Execute all applicable activities to comply with regulatory standards and quality management system requirements regarding supplier quality management.
• Perform technical reviews of suppliers to understand their manufacturing capacity.
• Supervise, evaluate, and monitor suppliers in manufacturing, process control, quality, corrective actions, continuous improvement, and first article inspection.
• Define and approve PPAP (Production Part Approval Process) requirements for all new and revised parts, and follow up on their timely completion.
• Work with suppliers to meet "fit, form, and function" and reliability requirements, collaborating internally with R&D and Design Assurance.
• Issue and follow up on Agile Quality figures such as "SCARs", "SACAs", and "NCEs" related to suppliers.
• Monitor the timelines of workflows to meet key performance indicators established by Hologic.
• Collaborate with suppliers on problem resolution and root cause analysis to prevent repeated failures, applying metrology and statistical measurement as appropriate.
• Work with Post Market Surveillance and other departments to address supplier-related complaints.
• Resolve daily supplier-associated issues globally, managing non-conformities, containment, and disposition of affected material (return, rework, selection, etc.).
• Collect and return samples to suppliers if necessary.
• After PPAP certification of a part number, work with Incoming Quality to include or exclude suppliers from the "Skip Lot Program" based on detected quality.
• Maintain complete supplier quality records according to applicable procedure (key indicators, certifications, etc.), updating files and ensuring accuracy and regulatory compliance.
• Support audits as a subject matter expert. National and international travel may be required.
• Update the ERP system with the status of approved suppliers for different materials.
• Attend functional and departmental meetings, following up on agreements.
• Coordinate and execute changes in specifications and/or procedures through the corresponding change order.
• Train in the respective procedures before executing tasks.
• Generate supplier performance metrics and reports for decision-making.
• Participate in periodic supplier review meetings and follow up on agreed activities.
• Coordinate and execute activities for the implementation of new suppliers by introduction or product transfer, ensuring compliance with requirements before project closure.
• Qualify new suppliers and/or new parts/components from an approved supplier.
• Perform other tasks as required by the supervisor/manager.

• Job Identification 12028
• Job Category Technical & Engineering
• Degree Level Bachelor's Level Degree
• Job Schedule Full time
• Locations Alajuela, Costa Rica