Quality System Engineer

Working at Freudenberg: We will wow your world!

• Supervise and assure a flawless execution of the corrective and preventive action system (CAPA).

• Supervise the correct usage of investigation tools and techniques in order to obtain effective corrective and preventive actions over the issues manage in the different quality systems.

• Be sure of having the correct follow up of action items related to the quality system in order to facilitate the closure of CAPAs, Nonconformance Material Records, Internal Audits and Complaints Investigations, as required.

• Create and Maintain a Roadmap for Compliance to Corporate/Site Commitments to External bodies and driving for effective implementation at Freudenberg Medical Costa Rica Site.

• Drive Freudenberg Medical Costa Rica to build a proactive quality Culture based on Substantial Compliance by providing relevant training, coaching, driving actions and critical disseminating of information to ensure.

• Drive Freudenberg Medical Costa Rica to be in a state of constant readiness to have successful audits by creating the procedures, driving behaviors and capabilities required to host external audits.

• Support Quality Management during the activities of preparation, management and hosting of External Audits.

• Develop continuous improvements initiatives of the Quality System by providing visibility and defining activities where we can anticipate changes in the regulatory landscape.

• Support the coordination and execution of the Management Review meetings and assure the proper documentation is kept, as per local/Corporate requirements.

• May oversee the management of the Internal Audit Program by the Internal Quality Auditor.

• Act as Internal Quality Auditor or Lead Auditor, as per established requirements, if required.

• Act as Independent Reviewer for significant projects or incidents that require this person´s level of expertise.

• Manage the Calibrations and Environmental Monitoring Departments

• Manage the Documentation Center Department.

• Bachelor's degree in industrial Engineer or Field Related.

• English Level desired: C1:(90-94%).

• Experience on managing regulations for medical device industry, ie ISO13485 & QSR 820

• Process control knowledge is a must.

• Experience managing people is a must.

• At least 3-5 years of experience in similar position.

• Quality System Integration knowledge and/or management is a plus

• Quality System and regulatory strategy for product transfer is a plus

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.