• A dynamic, fast paced, growing organization where personal development is encouraged
• Continued technical and on-the-job training

• Ensure that the procedures, rules and regulations of the organization are followed properly and according to requirements ISO 22716 and ISO 13485.
• Ensure that the procedures, rules and regulations of the USA FDA are followed properly and according to requirements and laws.
• Ensure that the employees and management handle matters appropriately, to ensure that procedures, regulations, rules, policies and laws are adhered to.
• Organize and guide all audits of external regulators such as FDA and ISO auditors.

• Develop and periodically review and update all procedures to ensure continuing currency and relevance in providing guidance to management and employees according to requirements ISO 22716 and ISO 13485.
  • Collaborate with other departments to direct compliance issues to appropriate existing channels for investigation and resolution according to requirements ISO 22716 and ISO 13485 and the FDA.
• Can assist investigation and resolution of any problems using existing resources.
• Begin the investigation process when there is a violation or suspected violation of a regulation, policy, rule or procedure.
  • Monitor the activities of all other departments to identify possible trends both positive and negative.
  • Perform internal audits according to requirements ISO 22716 and ISO 13485.
• Keep all contracts and agreements on file and updated.

• Bachelor’s degree required
• A minimum of 5 years experience
• Able to interact with people from other areas and communicate effectively with them the issues that are related to compliance
• Must be accurate and organized
• Familiarity with ISO, Regulators, Audits, operational, financial, quality assurance, and human resource procedures and regulations is a must.