Sr. Quality Specialist/Engineer

Flexible & Integrated Technical Services, LLC • Juncos, PR

2d • Onsite

About The Position

For Quality services in the Manufacturing/Engineering area. This role involves supporting quality assurance and compliance activities within a manufacturing environment, providing support for IT systems and integrations with manufacturing equipment, executing and supporting Computer Systems Validation (CSV) activities, ensuring compliance with quality systems, procedures, and applicable regulations, and collaborating with cross-functional teams to support manufacturing operations and continuous improvement initiatives.

Requirements

• Bachelor's Degree in Engineering or Life Sciences
• At least five (5) years of experience in Quality activities within the medical device industry
• Bilingual (English & Spanish)
• Experience in Quality Systems & Compliance
• Experience in Problem solving
• Experience in Computer Systems Validation
• Experience in IT Systems and integrations with manufacturing equipment
• Excellent communication skills
• Willingness to ask for help when needed
• Love of the scientific method
• Teamwork
• Ethical conduct

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 and continuous improvement initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior