Senior Quality Systems & CSV Specialist

FITS LLC; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

FITS LLC is seeking a qualified individual in Juncos, Puerto Rico for a role focusing on quality assurance and compliance within the manufacturing sector. The position requires a Bachelor's Degree in Engineering or Life Sciences and at least five years of related experience.

The ideal candidate will be bilingual, possess strong problem-solving skills, and be ready to collaborate on IT systems and quality regulations. Join a family-oriented company that emphasizes employee well-being and career growth.

Qualifications

• At least five years of experience in Quality activities within medical device industry.
• Ability to support IT systems and integrations with manufacturing equipment.
• Willingness to collaborate with cross-functional teams.

Responsibilities

• Support quality assurance and compliance activities within a manufacturing environment.
• Provide support for IT systems and integrations with manufacturing equipment.
• Execute and support Computer Systems Validation (CSV) activities.
• Ensure compliance with quality systems, procedures, and applicable regulations.
• Collaborate with cross-functional teams to support manufacturing operations.

Skills

Quality Systems & Compliance

Problem solving

Computer Systems Validation

Bilingual (English & Spanish)

Education

Bachelor's Degree in Engineering or Life Sciences

Job description

FITS LLC is seeking a qualified individual in Juncos, Puerto Rico for a role focusing on quality assurance and compliance within the manufacturing sector. The position requires a Bachelor's Degree in Engineering or Life Sciences and at least five years of related experience.

The ideal candidate will be bilingual, possess strong problem-solving skills, and be ready to collaborate on IT systems and quality regulations. Join a family-oriented company that emphasizes employee well-being and career growth.