Sr Quality Engineer QMS

Terumo BCTCartago, CR

Hace 16 días

Descripción del trabajo

Resumen de las funciones :

The Senior Quality Engineer (Quality Systems) is responsible for leading, maintaining, and continuously improving the organization's Quality Management System (QMS). This includes ensuring the establishment, implementation, enhancement, and compliance of the system in accordance with applicable international and local regulations (e.g., ISO 13485 : 2016, 21 CFR Part 820).

This role serves as a subject matter expert in Quality Systems, providing leadership in internal and external audits, managing Corrective and Preventive Actions (CAPA), overseeing non-conformance processes, and driving continuous improvement initiatives.

Tareas esenciales :

Responsible for the site's Internal Audit Program, including management and execution of the audit schedule.
Act as Lead Auditor during the execution of internal audits.
Provide support during external audits (Corporate, Regulatory, Notified Bodies) by serving as Backroom Leader, Frontroom Team Member, Scribe, Request Filler, etc.
Collaborate with Quality Systems leaders across different sites, regions, or business units to assess the effectiveness of the Quality Management System (QMS).
Participate in cross-functional teams for the development of new processes or changes to existing ones, providing input from a compliance and regulatory perspective.
Lead and manage the CAPA System, including root cause analysis and follow-up on actions, ensuring traceability and timely closure of each phase of the CAPA process.
Coordinate logistics and preparation for the CAPA Review Board meetings, ensure updates and closure of actions generated during the meeting, and prepare and disseminate meeting minutes when required.
Generate and analyze Quality System metrics for Management Reviews and other organizational forums.
Develop and update procedures, work instructions, and documentation related to the quality systems under responsibility.
Support the implementation of improvements in the Nonconformance process.
Support the implementation of enhancements to the Quality System and Operational Processes from a compliance and regulatory standpoint.
Serve as a subject matter expert in regulations and standards for cross-functional teams.
Ensure that Terumo BCT Costa Rica’s Quality Systems are in compliance with Corporate and Regulatory requirements.
Facilitate training sessions on QMS-related topics as required.
Coordinate logistics and preparation for Trending Review meetings, ensure updates and closure of actions generated during the meeting, and prepare and disseminate meeting minutes when required.
Coordinate logistics and preparation for Management Review meetings, ensure updates and closure of actions generated during the meeting, and prepare and disseminate meeting minutes when required.

Educación :

Bachelor’s or Licentiate Degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical, or Materials Engineering, or a professional degree in Health Sciences or related fields, with equivalent education and experience sufficient to successfully perform the essential functions of the role.

Desired English proficiency level : B2 (80–90%).

Strong knowledge of Root Cause Analysis methodologies.

Experience working in organizations regulated by 21 CFR Part 820 and ISO 13485 : 2016.

Ability to perform critical reviews and provide feedback on Quality records.

Excellent technical writing skills.

Excellent communication skills.

Strong problem-solving skills.

Licencias o certificaciones :

ISO 13485 : 2016 Lead Auditor Certification (considered a plus).

Desired knowledge : Formal training in Statistics, ASQ Certifications, and familiarity with Six Sigma methodologies.

Experiencia :

Minimum of 5 years of prior experience in the medical device or pharmaceutical industry related to Quality Systems Management.

Resumen de las funciones :

Tareas esenciales :

Responsible for the site's Internal Audit Program, including management and execution of the audit schedule.

Act as Lead Auditor during the execution of internal audits.

Provide support during external audits (Corporate, Regulatory, Notified Bodies) by serving as Backroom Leader, Frontroom Team Member, Scribe, Request Filler, etc.

Collaborate with Quality Systems leaders across different sites, regions, or business units to assess the effectiveness of the Quality Management System (QMS).

Participate in cross-functional teams for the development of new processes or changes to existing ones, providing input from a compliance and regulatory perspective.

Lead and manage the CAPA System, including root cause analysis and follow-up on actions, ensuring traceability and timely closure of each phase of the CAPA process.

Coordinate logistics and preparation for the CAPA Review Board meetings, ensure updates and closure of actions generated during the meeting, and prepare and disseminate meeting minutes when required.

Generate and analyze Quality System metrics for Management Reviews and other organizational forums.

Develop and update procedures, work instructions, and documentation related to the quality systems under responsibility.

Support the implementation of improvements in the Nonconformance process.

Support the implementation of enhancements to the Quality System and Operational Processes from a compliance and regulatory standpoint.

Serve as a subject matter expert in regulations and standards for cross-functional teams.

Ensure that Terumo BCT Costa Rica’s Quality Systems are in compliance with Corporate and Regulatory requirements.

Facilitate training sessions on QMS-related topics as required.

Coordinate logistics and preparation for Trending Review meetings, ensure updates and closure of actions generated during the meeting, and prepare and disseminate meeting minutes when required.

Coordinate logistics and preparation for Management Review meetings, ensure updates and closure of actions generated during the meeting, and prepare and disseminate meeting minutes when required.