Compliance Investigator conducts investigations of alleged violations of the corporation's ethical standards or non-compliance with applicable laws, regulations and corporate policy. Ensures that investigations follow the approved process, are lawfully and objectively conducted, are thorough in gathering all material facts and present an accurate accounting of the issues. Being a Compliance Investigator presents clear, concise, and factual reports that enable fair and relevant decisions to be made. Recommends proactive measures that will reduce the risk of similar future incidents. Additionally, Compliance Investigator typically requires a bachelor's degree. Typically reports to a manager or head of a unit/department. May require a Certified Fraud Examiner (CFE) certification. The Compliance Investigator contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. To be a Compliance Investigator typically requires 4 to 7 years of related experience. (Copyright 2024 Salary.com)
Description
Qualifications and Responsibilities:
• Quality/Compliance Management experience with AS9100, ISO13485, NADCAP Chemical Processing: 5 years (Preferred)
• Audit Representative – Maintain Quality System in compliance with applicable standards including AS9100, ISO13485 and NADCAP Chemical Processing. Represent the company during all quality audits.
• Review, understand and implement internal and external customer requirements to establish, develop, and review quality criteria and specifications for raw materials, products, and processes.
• Ensure all quality criteria and requirements are met by incoming customer products and raw materials, and final product/finished goods.
• Develop, maintain and update written policies and procedures.
• Documentation and Revision Control
• Conduct internal audits on a periodic basis to verify compliance with applicable policies and procedures.
• Conduct supplier quality audits.
• Oversee Corrective Action/ Preventive Action program.
• Provide quality and compliance guidance and feedback to employees at all levels and functional areas.
• Solicit feedback from customers to assess whether their requirements are met.
• Submit detailed reports to appropriate Management.
• Key team member and contributor to Continuous Improvement Program.
• Product/process/machine validation (IQ/OQ/PQ) experience
Requirements
• 5 years preferred as Compliance/Quality Manager/ ISO Management Representative
• Proven excellent interpersonal, verbal, and written communication skills.
• Organizational, leadership, and project management skills
• Proficient in MS Office
• In-depth understanding of quality control/assurance procedures and standards
• Strong root cause analysis skills
• Knowledge of pFMEA (process failure modes effects analysis) completion
• Excellent math abilities and working knowledge of data analysis/statistical methods.
• Solid understanding of the current standard revisions of NADCAP Chemical Processing, iSO13485, and AS9100
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