QC Manager

Job Responsibilities: 

• Oversee and drive the execution of the site's quality management system, ensuring compliance with corporate directives, industry standards, regulatory requirements, and customer expectations.
• Serve as the primary Quality Representative at the site, conducting regular quality management reviews and engaging with third-party auditors, regulatory bodies, and customers to maintain compliance.
• Promote a culture of continuous improvement by analyzing site data, implementing best practices, and driving quality initiatives to enhance processes, products, resources, and customer satisfaction.
• Monitor and report key quality performance metrics while managing corrective actions to ensure sustained improvement.
• Lead and oversee quality control activities, including material sampling, final product inspections, calibrations, testing, and process monitoring, ensuring timely execution and adherence to priorities.
• Provide feedback to stakeholders and implement corrective actions to uphold data integrity and product conformity in alignment with the quality management system (QMS) and regulatory standards.
• Strengthen the quality system by managing deviations, change controls, documentation, and corrective/preventive actions (CAPA) to mitigate risks and enhance overall quality.
• Ensure the Quality Control team operates efficiently, meeting QMS requirements and customer specifications.
• Lead, mentor, and develop assigned staff, fostering growth through training and career development opportunities.
• Oversee and collaborate on budget planning while managing resources effectively to optimize spending.
• Communicate regularly with key internal stakeholders to align quality objectives with business goals
• Establish and nurture strong relationships with internal and external partners to enhance the company’s competitive advantage.

Qualifications:

• 7+ years of experience within Quality Assurance / Quality Control
• Knowledge of applicable regulatory, standards global manufacturing practices, such as local regulations, cGMP requirements and ISO standards (i.e ISO 9001, ISO 13485, and/or TS 16949 standards)
• High-level understanding of all aspects of cGMP’s in validation, quality, and metrology operations. ‒ Knowledge of CAPA: process, features techniques