Compliance Manager - Healthcare implements and administers programs, policies, and practices to ensure that organization complies with JCAHO, HIPAA, and accreditation standards. Monitors and administers compliance with federal, state, and local regulations. Being a Compliance Manager - Healthcare acts as a liaison to government agencies and coordinates site visits for regulators. Investigates potential compliance violations and takes corrective action as necessary. Additionally, Compliance Manager - Healthcare requires a bachelor's degree. Typically reports to a head of a unit/department. The Compliance Manager - Healthcare 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. Extensive knowledge of department processes. To be a Compliance Manager - Healthcare typically requires 5 years experience in the related area as an individual contributor. 1 to 3 years supervisory experience may be required. (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
Clear All
0 Compliance Manager - Healthcare jobs found in Salisbury, NC area