Senior Quality Systems Lead – Regulatory & CAPA On-Site

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

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.