Compliance Specialist

Education / Licensing / Certification Requirements:

• B.S. or B.A. degree
• ISO 13485 and ASQ Certified Quality Auditor certifications preferred

Experience Requirements:

• 1-3 years minimum related work experience as auditor in FDA-regulated industry.
• Results orientation - focuses on goals and achieves results despite obstacles, disruptions and administrative requirements of the job; offers constructive alternatives to ineffective/inefficient processes.
• Communicates with others openly, while maintaining self-confidence and self-esteem, of others; keeps manager and others informed of relevant information and proactively communicates both good and bad news, giving information on impact and options.
• Work effectively and efficiently both individually and within a team environment.
• Complaint handling or previous experience in root cause analysis.

Position Overview: This is a permanent position that supports the execution of Internal Compliance Audits and Complaint handling to ensure conformance to domestic and international regulatory requirements.

This position reports to: Vice President, RA/QA & Organizational

Responsibilities (essential job responsibilities):

Participates in and coordinates regulatory compliance activities including internal audits, CAPA and investigations of product complaints. Assists in the management of the complaint system database and coordinates corrective actions. Ensures complaints are investigated to determine root cause and documents corrective actions.

• Maintains complaint handling and investigation procedures.
• Performs investigations of product complaints, ensuring that all complaints are investigated to determine root cause.
• Where necessary, coordinates investigation activities with other departments. Maintains accurate investigation information.
• Supports Corrective Action & Preventive Actions (CAPAs) by investigation and root cause analysis.
• Performs internal audits to ensure compliance to FDA. ISO and other international requirements.

Promotion Path: TBD

If you are interested in this position, please call or email Human Resources (ext. 4650) as soon as possible to discuss your interest. You must meet the job qualifications along with 6 months of tenure at OsteoMed to be considered.