Quality Applications Specialist: Validation & Compliance

ECHO Consulting Group Inc; Villalba (PR); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

ECHO Consulting Group is a leader in quality management, regulatory compliance, and CQV for the pharmaceutical and medical device industries. The role focuses on validating quality IT systems, ensuring compliance with FDA and ISO standards, and guiding cross-functional teams.

The candidate should have a Bachelor's in Engineering or Science and 10+ years in medical devices, with strong CAPA/FCA experience and excellent communication skills. 1st shift, Villalba, PR location.

Qualifikationen

• 10+ years of experience in the medical device industry.
• Strong knowledge of FDA regulations (21 CFR Part 820) and ISO 13485.
• Proven ability in FCA and CAPA processes within regulated environments.

Aufgaben

• Conducts a compliant validation process for quality information technology systems with formal documentation under federal regulations.
• Coordinates activities with clients, programmers/developers and operating personnel, domestically and globally.
• Identifies requirements for compliant computerized operations and documents procedures and actions.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements and audit policies.
• Performs system administration and configuration of quality information technology systems.

Kenntnisse

Autonomy

Organizational impact

Innovation

Communication

Leadership

Knowledge & experience

Ausbildung

Bachelor's degree in Engineering or Science

Tools

Microsoft Office

Quality Management Systems (QMS)

Jobbeschreibung

ECHO Consulting Group is a leader in quality management, regulatory compliance, and CQV for the pharmaceutical and medical device industries. The role focuses on validating quality IT systems, ensuring compliance with FDA and ISO standards, and guiding cross-functional teams.

The candidate should have a Bachelor's in Engineering or Science and 10+ years in medical devices, with strong CAPA/FCA experience and excellent communication skills. 1st shift, Villalba, PR location.