Senior Compliance Specialist

Our client is a leading OEM supplier of products and services for medical devices and procedures.

The primary purpose of this position is to execute and implement the following: Complaint Handling, MDR and Vigilance reporting, CAPA, Field Action execution, leading quality audits and Compliance Consulting for Greatbatch manufacturing facilities, under the direction of the Global Quality Systems and Compliance Program Manager. This position will also be responsible for developing and managing processes that comply with national and global regulatory requirements. This position may also conduct detailed quality analysis and trending of data.

Education/Experience:

Bachelor’s degree required. 7+ years Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or Diagnostics industry.

Specialized knowledge needed for performance of job:

• Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485).
• Problem Solving and training skills.
• Proficient in Microsoft Office applications required.
• Familiarity with eQMS Programs (TrackWise, EtQ, etc.) desired.

ESSENTIAL FUNCTIONS INCLUDE

• Adheres to Company's Core Beliefs and all safety and quality requirements.
• Responsible for performing complaint investigations including: documentation of complaint, working with manufacturing facilities to complete complaint investigations, and determining need to escalate issues.
• Responsible for MDR and Adverse Event reporting activities.
• Interacts with Engineers and Enterprise Management in working to complete post-market health risk assessment activities.
• Leads CAPA compliance activities for the enterprise CAPA board. Support CAPA investigations as needed.
• Executes field actions including: reconciliation of returned products, monthly status reporting, and oversight of corrective actions.
• Provides Quality Systems and Compliance consulting to manufacturing sites related to CAPA, Complaint Investigations, and other compliance topics. Assist in keeping company informed of US and International regulatory requirements.
• Provides support for external regulatory inspections and assists Global Quality Systems and Compliance Program Manager in review of responses to external non-conformances and findings.
• Leads and participates in Quality and Compliance Audits.
• Plays an active role in development and maintenance of the Enterprise Quality Management System under the direction of the Global Quality Systems and Compliance Program Manager and the QS Director.
• Independently performs assignments, receiving instruction only regarding general expected results.
• Performs other functions as required.