Sr. Quality Specialist/Engineer

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

For Quality services in the Manufacturing/Engineering area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Engineering or Life Sciences and at least five (5) years of experience in Quality activities within the medical device industry.
• Bilingual (English & Spanish).
• Shift: Administrative and according to business needs
• Experience in:
  • Quality Systems & Compliance
  • Problem solving
  • Computer Systems Validation
  • IT Systems and integrations with manufacturing equipment

The Personality Part:

• If you have excellent communication skills and aren’t afraid to ask for help when you need it (in addition to your excellent Maintenance skills), this might be the job for you! Sprinkle on a love of the scientific method, teamwork, and, above all else, being ethical, and you just might have what it takes to take on this new challenge. Bring it on!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• 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 and continuous improvement initiatives.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the next piece?