Quality Systems Leader: CAPA, Audits & Compliance

PRC Medtronic PR Operations Co.; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Medtronic is seeking a Quality Systems Specialist to maintain and continuously improve the quality management system, ensuring compliance with internal procedures and external regulatory requirements. The role supports document control, CAPA, complaints, training, and quality records while partnering with cross-functional teams to drive product and process quality.

Responsibilities include leading audit and inspection preparation, addressing findings, and ensuring consistency of global quality

Qualifications

• Bachelor's degree in a related field is required.
• Experience with quality systems in a regulated environment is preferred.
• Familiarity with CAPA, document control, deviations, change control and complaints is beneficial.
• Experience supporting internal or external audits is advantageous.

Responsibilities

• Maintain and improve the quality management system to ensure compliance with internal procedures and external regulations.
• Oversee document control, CAPA, complaints, training and quality records.
• Lead audit and inspection preparation and coordinate with auditors and inspectors.
• Collaborate with cross-functional teams to identify opportunities for improvement and drive product and process quality.

Skills

Quality systems

Audit readiness

CAPA

Document control

Regulatory compliance

Cross-functional collaboration

Data analysis

English communication

Education

Bachelor's degree in related field

Tools

QMS software

Job description

Medtronic is seeking a Quality Systems Specialist to maintain and continuously improve the quality management system, ensuring compliance with internal procedures and external regulatory requirements. The role supports document control, CAPA, complaints, training, and quality records while partnering with cross-functional teams to drive product and process quality.

Responsibilities include leading audit and inspection preparation, addressing findings, and ensuring consistency of global quality