Quality Assurance Manager

About the role

TekniPlex Healthcare is looking for a senior Quality Assurance Manager to lead the Quality Management System at its Cartago, Costa Rica site. The role will ensure compliance with ISO 13485, FDA regulations and drive continuous improvement across the organization.

Key responsibilities

• Act as the Site Management Representative, overseeing the effectiveness of the QMS in line with ISO 13485:2016.
• Lead customer complaint investigations, non-conforming material handling and CAPA processes to ensure timely resolution.
• Plan, execute and follow‑up internal, customer and regulatory audits, including FDA and Notified Body assessments.
• Support validation, verification and process monitoring activities for manufacturing operations.
• Develop, coach and mentor a high‑performing quality team, fostering a culture of quality and operational excellence.

Required profile

• Bachelor’s degree in Engineering, Quality Management, Life Sciences, Industrial Engineering or a related field.
• Minimum 10 years of quality assurance experience in a regulated manufacturing environment, with proven leadership responsibilities.
• Experience managing QMS compliance with ISO 13485 and FDA 21 CFR Part 820.
• Demonstrated ability to lead customer audits, regulatory inspections and manage CAPA programs.

Required skills

• ISO 13485:2016 knowledge
• FDA 21 CFR Part 820 expertise
• Six Sigma Black Belt certification (preferred)
• Statistical analysis and root‑cause investigation
• Validation, verification and process monitoring techniques
• Quality tools and continuous‑improvement methodologies