Quality Engineer II at Heraeus Medevio developing engineering solutions for manufacturing complaints and quality issues. Leading teams to improve product and process quality in Cartago, Costa Rica.
About the role
- Sr QA Specialist overseeing NC CAPA processes in regulated MedTech environment. Collaborating with stakeholders and supporting investigations while ensuring compliance and quality management.
Responsibilities
- Support NC/CAPA system and process user training
- Facilitate the initiation of investigations and CAPAs and monitor progress to ensure timely completion
- Execute quality reviewer/approver duties, review evidence, and approve closure of NC and CAPA records
- Conduct investigation record quality reviews for documentation completeness, robust root-cause analysis, and compliance with procedures
- Monitor CAPA effectiveness and confirm root cause is eliminated or reduced to an acceptable level
- Use data analytics and trending to identify failure modes, measure CAPA effectiveness, and inform continuous improvement priorities
- Collaborate with stakeholders, site owners, governance bodies, and senior management to resolve issues and align on corrective actions
Requirements
- Bachelor’s Degree in Life Science or related discipline or equivalent is required
- Minimum of 6 years’ experience in a regulated MedTech or Pharmaceutical Quality Systems Compliance field and/or equivalent experience/training in a related NC CAPA Investigation Quality System area
- Demonstrated experience as an investigator of Non-Conformance/CAPA process
- Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence
- Requires critical analytical and problem-solving skills, strategic thinker, and collaborator
- Ability to build consensus, influence, and negotiate
- Knowledge of Quality Management, Project Management and/or Process Excellence concepts and practices
Benefits
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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