Compliance Manager manages the compliance programs, policies, reporting, and practices for an organization or business. Ensures that all activities follow regulatory requirements related to the governance of the organization as well as any industry-specific or location-specific laws. Being a Compliance Manager oversees internal controls and auditing systems that monitor and report on regulated activities and processes. Implements risk-based compliance testing of existing procedures and controls to identify, detect, and correct noncompliance. Additionally, Compliance Manager evaluates and implements changes to compliance processes due to new or amended regulations. Delivers communication and training initiatives that inform stakeholders about compliance requirements. Requires a bachelor's degree or equivalent. Typically reports to a director. The Compliance Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Compliance Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (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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