On-Site Quality Systems Program Lead (Medical Devices)

Medial Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Medial Group in Puerto Rico seeks a seasoned Quality Compliance Lead to oversee quality programs, systems, and procedures ensuring regulatory adherence. You will guide interpretation of policies and collaborate with operating entities for ongoing process analysis.

Lead audits, manage finding resolutions, prepare CPAs, and liaise with inspectors. On-site in Juncos, you will drive continuous improvement and cross-functional collaboration across global standards.

Qualifications

• Minimum 5+ years in medical device design, development, and/or manufacturing.
• Proven track record leading cross-functional teams using project management methodologies.
• Strong negotiation and communication skills.
• Knowledge of medical device regulations.
• Experience with electrical functionality devices is an advantage.

Responsibilities

• Provide oversight for quality programs, systems, processes, and procedures.
• Lead audit and inspection preparation and liaison with auditors through all stages.
• Prepare reports and documentation for internal and external stakeholders.
• Coordinate legal requests supporting investigations or litigations.
• Monitor program performance and drive continuous improvements.

Skills

Quality management

Project management

Risk management

Cross-functional leadership

Communication

Negotiation

DMAIC

Process mapping

Education

Bachelor’s degree in Engineering or Sciences

Tools

DMAIC

Process mapping

5 Whys

Is/Is Not

Job description

Medial Group in Puerto Rico seeks a seasoned Quality Compliance Lead to oversee quality programs, systems, and procedures ensuring regulatory adherence. You will guide interpretation of policies and collaborate with operating entities for ongoing process analysis.

Lead audits, manage finding resolutions, prepare CPAs, and liaise with inspectors. On-site in Juncos, you will drive continuous improvement and cross-functional collaboration across global standards.