OneMain Financial Jobs

Lead, CAPA Supplier Quality Engineer CR

Alajuela, Costa Rica

Education / Educación:

• Advanced English proficiency (spoken and written) is required for effective communication in professional and technical contexts.

• BSdegree in Engineering, Life Sciences, or related field.

Experience / Experiencia:

• At least 8 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 the organization and within the professional medical industry cluster.

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

• Microsoft Office

• Internet

• Email

• Project, Visio, Mini Tab

• Agile: Yes (desirable)

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

Job Summary: Facilitates, advises, and reviews Corrective and Preventative Actions related to the Supplier Quality department, serving as process owner for the following different types of “CAPAs”:

• Corrective and Preventive Action (CAPA),

• Internal Audit Corrective Action (IACA),

• Supplier Corrective Action Reports (SCAR) and

• Supplier Audit Corrective Actions (SACAs)

An experienced professional with extensive knowledge in both the identification and escalation of issues, investigation and root cause documentation, and development of corrective action implementation plans. This person is to also have a working knowledge of medical devices manufacturing.

This role requires the ability to resolve a wide range of issues in creative ways and working and influencing members of various departments in an effective way. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Has a deep understanding of various aspects of the QMS and applies knowledge and skills to complete a wide range of tasks. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise ensuring organizational compliance with regulatory requirements, internal policies, and quality standards.

Essential Duties and Responsibilities:

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

· Models all quality values and supports others on quality system requirements and standards to elevate team's ability to produce high-quality/compliant products and implements best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvement.

· Collaborates and communicates effectively with various level employees, peers, and cross-functional teams across all levels of the organization.

· Responsible for the coordination of assigned quality efforts and provides support for the Supplier Quality department as directed by the Global Supplier Quality Director/Sr.Director.

· Manages, facilitates, and Supplier Quality CAPA records.

· Provides guidance and expertise on all aspects of the CAPA process flow from risk/escalation assessment through CAPA effectiveness post closure.

· Performs and participates in regular reviews of input sources to the NCE and CAPA processes to assist in determining escalations and coordinating with departments to ensure adequate status resourcing.

· Represent Supplier Quality on CAPAs during CAPA Review Board meetings, alongside CAPA owners.

· Owns and improves Supplier Quality CAPA awareness and training.

· Works on documentation and activities stemming from audits, management reviews, quality meetings, and divisional CAPA Review Board meetings.

· Serves as the Supplier Quality point of contact for various Quality processes for inputs to global process enhancements and training content.

· Participates in site internal and external quality audits including support of front and/or back room workstreams.

· Supports in audit preparation efforts including communicating with applicable functional areas and collecting data to ensure audit efficiency.

· Participates in the collection of divisional Management Review materials.

· Ability to modify, maintain, and create procedures and processes as applicable.

· Participates in periodic data analysis to develop trending and key performance indicators for various functions

• Acts as the Supplier Quality subject matter expert on CAPA, leveraging extensive knowledge of root cause analysis tools and applying risk management principles to CAPA initiatives and the Quality Management System.

• Evaluates KPI metrics to measure the effectiveness of the SQ’s CAPA, providing detailed trend analysis and performance reports to senior leadership.

• Review and approve CAPA documentation to verify the completeness of activities, adherence to good documentation practices, and compliance with regulatory standards.

• Facilitates (as applicable), SCARs and/or SACAs making sure investigations are robust, corrective and preventive action plans are commensurate to the risk, and verification of effectiveness has a solid statistical rationale.

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.

• High proficiency with Microsoft Office suite to produce reports, analyze data, etc. effectively.

• Working knowledge of Medical Device Regulations, cGMP, CFR 820, ISO-13485.

• Risk management know how.

• Root cause analysis tools (Fishbone diagrams, 8D, DMAIC, SPC, Root Cause Failure Analysis, Kepner-Tregoe, etc.).

• Knowledge in corrective/preventive actions

• Statistical know-how.