Sr. Quality Systems Specialist

Medial Group; Juncos (PR); On-site; USD 75,000 - 105,000; Full time

Job summary

Medial Group in Juncos, PR seeks a quality/compliance professional to oversee development, implementation, and maintenance of quality programs ensuring regulatory compliance. You will lead audits, coordinate with regulators, and drive continuous improvement across operations.

The role requires strong technical writing, investigation skills, and experience with Process Validation and CSV, with on-site work required.

Qualifications

• Minimum of 4 years of relevant experience in the regulated industry.
• Bachelor’s Degree completed with a minimum of 4 years of relevant experience.
• Master's degree with a minimum of 2 years of relevant experience.
• Willing to work 100% on-Site in Juncos, PR.

Responsibilities

• Provide oversight for the development, implementation, and maintenance of quality programs to ensure compliance with regulatory requirements and industry standards.
• Lead audit and inspection preparation activities; support and coordinate during audits; drive resolution of audit findings.
• Act as liaison with internal/external auditing groups and regulatory inspectors throughout the audit lifecycle.
• Maintain and regularly update quality assurance programs, procedures, and documentation to align with evolving standards.
• Coordinate legal and quality documentation requests in support of government investigations or litigations.
• Promote uniform global quality standards and facilitate best-practice sharing across sites.

Skills

Investigation skills

Technical writing

Communication skills

Root cause analysis

Education

Bachelor's degree

Master's degree

Job description

Provide oversight for the development, implementation, and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies, regulatory requirements, and industry standards.

Ensure the performance and quality of services conform to established Quality System standards, agency guidelines, and company expectations.

Offer expertise and guidance in interpreting regulatory, governmental, and internal quality policies to maintain compliance across operations.

Partner with operating entities to analyze processes, ensure requirement alignment, and drive continuous improvement initiatives.

Lead audit and inspection preparation activities; support and coordinate during audits; drive resolution of audit and inspection findings.

Act as liaison with internal/external auditing groups and regulatory inspectors throughout the entire audit lifecycle.

Coordinate legal and quality documentation requests in support of government investigations or litigations.

Maintain and regularly update quality assurance programs, procedures, and documentation to align with evolving standards and regulatory expectations.

Promote uniform global quality standards and facilitate best-practice sharing across sites and teams.

Other duties may be assigned.

Requirements

• Minimum of 4 years of relevant experience in the regulated industry.

Top 3 Required Experience Areas:

• Strong investigation skills with demonstrated root cause analysis capabilities.
• Proficient technical writing, strong organization, and effective communication skills.
• Experience in Process Validation and Computer Software Validation (CSV).
• Bachelor’s Degree completed with a minimum of 4 years of relevant experience.
• Master's degree with a minimum of 2 years of relevant experience.
• *Willing to work 100% on-Site in Juncos,PR.*