Principal Quality Systems Spec

Medial Group; Juncos (PR); On-site; USD 120,000 - 160,000; Full time

Job summary

Medial Group in Juncos, Puerto Rico, seeks a seasoned Quality Systems leader to oversee the development and maintenance of quality programs, ensuring compliance with policies and regulatory guidelines.

The role requires 8+ years in a regulated industry (medical devices preferred), with hands-on experience in CAPA, change control, validations, and audits.

Willing to work 100% on-site in Juncos, PR, delivering projects from design to implementation and mentoring colleagues as needed.

Qualifications

• Bachelor’s Degree in Science or Engineering.
• 8+ years of experience in a regulated industry (medical devices preferred).
• Experience in Quality Systems oversight including CAPA, change control, and validations.
• Strong knowledge of Medical Device Regulatory Requirements (FDA, ISO, etc.).
• Hands-on experience supporting Quality & Regulatory Audits (internal, external, agency).

Responsibilities

• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and regulatory guidelines.
• Ensures performance and quality of services meet established standards and agency expectations.
• Leads audit and inspection preparation, manages resolution of audit findings, and liaises with auditing groups and inspectors through all audit stages.
• Coordinates legal requests in support of government investigations or litigations.
• Facilitates uniform standards worldwide and enables best practice sharing across the organization.
• Delivers and oversees assigned projects from design to implementation while adhering to policies and utilizing specialized expertise.
• May mentor colleagues or direct work of lower-level professionals.

Skills

Quality Systems Oversight

CAPA

Change Control

Validations

Regulatory Audits

Education

Bachelor’s Degree in Science or Engineering

Job description

Juncos, Puerto Rico | Posted on 11/20/2025

Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and regulatory guidelines.

Ensures the performance and quality of services meet established standards and agency expectations.

Provides expertise and guidance in interpreting policies, regulatory, and/or governmental regulations.

Works directly with operating entities to provide process analysis oversight on a continuing basis.

Leads audit and inspection preparation, manages resolution of audit findings, and liaises with auditing groups and inspectors through all audit stages.

Coordinates legal requests in support of government investigations or litigations.

Ensures quality assurance programs and policies are maintained and updated regularly.

Facilitates uniform standards worldwide and enables best practice sharing across the organization.

Delivers and oversees assigned projects from design to implementation while adhering to policies and utilizing specialized expertise.

May mentor colleagues or direct work of lower-level professionals.

Other duties may be assigned.

Requirements

Education: Bachelor’s Degree in Science or Engineering.

Experience: Minimum 8+ years of experience in a regulated industry (medical device preferred).

Must-Have Experience:

• Quality Systems oversight, including CAPA, Change Control, and Validations.
  
• Strong knowledge of Medical Device Regulatory Requirements (FDA, ISO, etc.).
  
• Hands-on experience supporting Quality & Regulatory Audits (internal, external, agency).
  

*Willing to work 100% on-Site in Juncos, PR.