Job Description

Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly.

Skills/Qualifications:

Previous experience on Quality Systems & CAPA, Change Control and Validations. Knowledgeable on Medical Device Regulatory Requirements. Previous experience with Quality & Regulatory Audit activities.

Work Shift: 1st Shift

Education/Experience:

Bachelors degree with 8 years of directly related experience.
Job Types: Full-time, Contract

Benefits:

Paid time off
Work Location: In person