Job Description

Job Summary

Plastikon Healthcare is seeking an experienced Sr. Quality Compliance Manager to lead and oversee our quality management systems within a manufacturing environment. The ideal candidate will ensure compliance with industry standards and regulations, including ISO & FDA regulations and cGMP. This role involves managing quality audits, implementing quality assurance processes, and maintaining rigorous quality control measures to uphold product safety and excellence. The Sr. Quality Compliance Manager will play a pivotal role in driving continuous improvement initiatives and ensuring adherence to regulatory requirements across all operational facets.

Responsibilities

• Develop, implement, and maintain comprehensive quality management systems aligned with ISO & FDA regulations and cGMP standards.
• Lead internal and external quality audits to verify compliance with regulatory standards and company policies.
• Oversee quality control and inspection processes to ensure products meet specified standards and customer expectations.
• Manage quality assurance activities across manufacturing operations, including process validation and risk assessments.
• Collaborate with cross-functional teams on project management initiatives related to quality improvements and compliance efforts.
• Conduct analysis of quality data to identify trends, root causes of issues, and opportunities for process enhancements.
• Ensure documentation accuracy and regulatory reporting requirements are consistently met.
• Provide training and guidance on quality systems, policies, and procedures to staff at all levels.
• Act as the primary liaison during regulatory inspections and audits, ensuring readiness and effective communication.
• Responsible for managing the NCR/CAPA and Change Control programs.
• Maintain effective relationships with global regulators to understand current and anticipate proposed regulation to remain in regulatory compliance.
• Perform other related duties as assigned or required.

Experience

• Proven experience in a senior quality management role within a manufacturing or medical device environment.
• Bachelor's degree required.
• Minimum 7 years’ experience in pharmaceutical and / or quality assurance. 10 years is preferred.
• Extensive knowledge of ISO & FDA regulations, cGMP and related regulatory frameworks.
• Demonstrated expertise in conducting quality audits, inspections, and implementing QA/QC procedures.
• Strong background in quality control, quality inspection, and overall quality assurance practices.
• Experience managing quality systems within regulated industries with a focus on compliance and continuous improvement.
• Project management skills with the ability to lead cross-functional teams effectively.
• Excellent analysis skills for interpreting data trends and driving strategic decisions related to product safety and compliance. This position offers an opportunity for a dedicated professional to influence the integrity of our products while ensuring strict adherence to industry standards. The ideal candidate will possess a strong foundation in quality management principles combined with leadership capabilities essential for fostering a culture of excellence across the organization.

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