Principal Quality Systems Spec

Juncos - Puerto Rico

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

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: Bachelors 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.

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 guidanc...