On-Site Quality Applications Specialist

Medial Group; Puerto Rico; On-site; USD 85,000 - 110,000; Full time

Job summary

Medial Group in Villalba, Puerto Rico, seeks a Quality Application Specialist to support quality and product transfer activities in a regulated medical device environment, focusing on process validation and product commercialization while ensuring FDA and international regulatory compliance.

The role requires coordinating product transfers, executing validation lifecycles, validating quality systems, and driving First Time Quality through data analysis and PFMEA.

Qualifications

• Bachelor's Degree in Engineering, Science, or related technical discipline.
• 3 to 6 years in Medical Device, Pharmaceutical, Biotechnology, or other FDA-regulated industries.
• Experience supporting product transfer and commercialization activities.
• Knowledge of GMP and quality system regulations.

Responsibilities

• Support product transfer activities from development through commercial release.
• Execute and maintain process validation lifecycle activities, including protocol development, execution, analysis, and reporting.
• Conduct validation activities for quality information technology systems, ensuring regulatory compliance.
• Develop, review, and maintain validation documentation (SOPs, validation plans, protocols, reports).
• Support sterilization processes and validation activities to ensure compliance with standards.
• Provide quality oversight for final packaging operations and validation requirements.
• Perform statistical analysis to evaluate process performance, capability, and validation results.
• Lead or support PFMEA activities to identify and mitigate process risks.
• Drive First Time Quality initiatives through data analysis and root cause investigations.
• Coordinate activities with cross-functional teams (Manufacturing, Quality, Engineering, Regulatory).

Skills

Statistical analysis

PFMEA

Root cause analysis

GMP knowledge

Cross-functional teamwork

Education

Bachelor's Degree in Engineering, Science, or related technical discipline

Tools

Computer System Validation (CSV)

Job description

Medial Group in Villalba, Puerto Rico, seeks a Quality Application Specialist to support quality and product transfer activities in a regulated medical device environment, focusing on process validation and product commercialization while ensuring FDA and international regulatory compliance.

The role requires coordinating product transfers, executing validation lifecycles, validating quality systems, and driving First Time Quality through data analysis and PFMEA.