Job Description

Location MV

Alajuela, Costa Rica

Department Name

3211-CR-Quality

Qualifications

1. Bachelor’s degree in engineering, Science, or a related field of study.
2. Minimum five (5) years of quality assurance/compliance related work experience in the medical device industry.
3. Must be able to handle multiple projects concurrently and have computer experience and knowledge of FDA Regulations and Application of Good Manufacturing practices.
4. Demonstrated understanding of and adherence to Good Documentation Practices.
5. Demonstrated experience using investigation techniques and root cause investigation tools, determining appropriate and effective corrective actions, and thoroughly documenting CAPAs.
6. Strong interpersonal and verbal and written communication skills; team player with good problem-solving ability.
7. Strong analytical skills and attention to detail.
8. Successful experience working independently as well as collaboratively, effectively, and confidently in a team environment.
9. Ability to partner with associates at various levels within the organization.
10. Proficient computer skills, including MS Word, Excel, PowerPoint, Visio, Outlook, and Teams.
11. B2 English proficiency.

Desired Qualifications

1. Lean Six Sigma, Quality, and/or Project Management related certification, preferred.
2. Knowledgeable in 21CFR Part 820, ISO13485, ISO14971, EMDR/MDD, MDSAP and CMDCAS regulations.