MAIN PURPOSE OF ROLE
This position is responsible for integrating and maintaining quality systems and providing quality management system
support for the Costa Rica site. This includes but no limited to proactive compliance to all applicable standards,
divisional quality management system and documentation integration, harmonization and improvement.
Provides Quality Management System Body of Knowledge support to the organization.
Position will be responsible of the personnel in charge for facilitation, training and development
Lead cross functional teams to execute Quality Management System initiatives.
As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g.,
represent the Quality System function as a Team Member)
Draft, review, and update Quality Management Systems support documentation to proactively comply with
applicable internal, domestic, and international standards or regulations.
Supports the coordination of the external audits / inspections preparation and support and / or participate during
external audits, as required.
Ensures compliance to ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation
of regulations, performing gap analysis and lead activities to implement improvements.
Identify opportunities for improvement regarding compliance to applicable industry standards and regulations.
i.e. US FD&C, 21CFR11, 21CFR820; EN ISO 13485; EN ISO 14971; EU MDD 93 / 42 / EEC; etc.)
Supports investigating and resolving system nonconformance’s (defined during internal and / or external audits).
Works with the organization during change management process and new product introductions to ensure quality
deliverables such as Quality Plans and Risk Management are in place for the products being transferred.
Evaluates regulations to translate requirements into user friendly Standard Operating Procedures and Work
Administers the CAPA System elements, Quality Management Review and Quality Data Review for the site.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company
policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers,
contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Bachelor Degree Engineering, Business Administration, Human Resources or Science.
Bachelor’s Degree with demonstrated experience in Quality, Engineering or work within structured processes, desirable in Medical Devices.
At least 5 years experience, with 3+ years in Quality Systems or Compliance positions.
1 year experience in supervision role. 3 years of experience in an FDA (QSR), ISO 13485 or ISO 9001 controlled industry.
Quality Auditor training for ISO 13485 or 9001
Experience in process improvement such as : Root Cause Analysis (Fishbone, Is / Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).
Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
Advance command of English required.
Preferred Qualifications & Education
Masters (in progress or completed) on Quality Management, Operational Excellence, Project Management or similar.
Prior medical device experience.
Six Sigma familiarity or experience desired.
Certified Quality Engineer.
Quality Systems related certifications (Quality Control, CAPA, Risk Management, etc).
2 years of experience participating on ISO and / or FDA audits is a plus.