Quality and Compliance Manager

Description

The Quality Manager is responsible for leading the organization’s quality assurance and compliance programs, ensuring that all products and processes meet or exceed customer, ISO, regulatory, and statutory requirements. This role oversees the Quality Management System (QMS), drives continuous improvement initiatives, manages internal and external audits, and serves as the primary representative for quality-related matters with customers, vendors, and regulatory bodies.

The Quality Manager fosters a culture of excellence, accountability, and ongoing improvement throughout the organization.

• Plan, direct, and coordinate quality assurance programs; formulate quality control policies.
• Oversee and maintain the Quality Management System (QMS), ensuring compliance with ISO 9001/13485, FDA, and other relevant standards.
• Monitor performance of quality control systems to ensure effectiveness and efficiency. Review and update SOPs and quality manuals.
• Oversee facilitation of change control process for documented information; ensure change control is followed and meets QMS requirements.
• Ensure customer requirements are determined, reviewed, and managed through the QMS.
• Oversee external standards and customer health/safety communication requirements.

• Monitor for trends that could lead to quality issues and opportunities for process improvements.
• Collaborate with cross-functional teams to determine actions, resource needs, and time frames.
• Support process/project improvement teams as needed.
• Verify/validate resulting changes; ensure supporting documentation is updated and communicated.

• Lead root cause investigations for process and product nonconformities, using methodologies such as 8D, PFMEA, Six Sigma.
• Manage and verify the effectiveness of corrective and preventive actions (CAPA). Accountable for the corrective action process.
• Implement processes/tools for reporting nonconformities; ensure root causes are investigated, documented, and appropriate corrective actions are taken.
• Analyze quality control test results and provide feedback to production management or staff.
• Drive continuous improvement initiatives to enhance operational efficiency and quality performance.
• Verify completion of corrective actions according to documented timelines; report results to customers, registers, and regulatory bodies.
• Evaluate effectiveness of all corrective actions.

• Schedule and facilitate internal and external audits; ensure timely closure of audit nonconformities.
• Ensure compliance to QMS management review reporting of inputs/outputs; facilitate management review meetings and maintain Business Risk Register.
• Represent the organization in external/customer audits.
• Ensure the QMS is documented and effective; report on the health of the QMS and related processes.
• Prepare, review, and maintain accurate documentation of compliance activities, including complaints, investigations, and audit outcomes.
• Responsible for implementing and monitoring management review process, quality policy, and quality objectives.

• Serve as the organizational representative for quality-related matters with customers and vendors.
• Access customer portals to retrieve, enter, and update quality-related information, including the completion and submission of supplier surveys, scorecards, and compliance documentation as required by customers.
• Collaborate with customers and vendors to resolve quality issues/complaints, communicate corrective actions, and support supplier quality improvement initiatives.
• Ensure timely and accurate response to customer requests for quality data, corrective actions, and audit documentation.
• Collaborate with suppliers to ensure quality requirements are met; support supplier quality improvement initiatives.

• Train and mentor personnel on quality standards, procedures, and QMS documentation.
• Develop and implement quality training programs for employees.
• Foster an environment where quality standards are understood, valued,…