Quality Manager

Responsibilities:

• Lead, mentor, and manage assigned quality personnel to ensure optimal performance and alignment with company goals. Act as the primary advisor to senior management regarding Quality Management System (QMS) performance, providing data-driven insights and recommendations for improvement.
• Continuously monitor and track key performance indicators (KPIs) related to quality, ensuring accuracy and timeliness in generating detailed reports at regular intervals. Analyze trends and provide actionable insights to drive quality improvements.
• Oversee the organization, maintenance, and accuracy of document control systems, ensuring all quality-related documents are up to date and compliant with regulatory requirements. Manage related databases to ensure seamless access and retrieval of critical quality documents.
• Review and assign corrective actions to appropriate personnel, ensuring timely implementation. Validate the effectiveness of corrective and preventive actions (CAPA) by conducting thorough follow-ups and verifying that root causes have been addressed.
• Champion continuous improvement efforts by identifying and driving initiatives aimed at enhancing overall product quality, process efficiency, and regulatory compliance. Foster a culture of continuous improvement throughout the organization.
• Ensure the timely planning, execution, and closure of internal, supplier, and customer audits. Collaborate with cross-functional teams to address audit findings, implement corrective actions, and ensure compliance with quality and regulatory standards.
• Lead efforts to ensure the organization’s operations and products comply with all applicable regulatory standards, including ISO 13485 and FDA 21 CFR Part 820. Provide guidance to ensure regulatory requirements are met throughout product design, manufacturing, and post-market activities.
• Implement and maintain a robust Quality Management System (QMS) in accordance with ISO 13485 and FDA 21 CFR Part 820 standards. Continuously evaluate and update the QMS to ensure it aligns with current best practices and evolving industry standards.
• Develop, implement, and validate quality procedures, work instructions, and operational protocols. Ensure that all procedures are thoroughly documented, accessible, and adhered to by all relevant stakeholders.
• Lead regular Management Review meetings to evaluate the overall performance of the QMS. Present key quality metrics, audit findings, and regulatory compliance updates. Follow up on all identified action items to ensure timely and effective resolution.

Qualifications:

• A bachelor’s degree in Engineering or a related technical field is required. A Master’s degree or advanced certifications in Quality Management is a plus.
• A minimum of 5–10 years of hands-on experience in Quality Engineering within a manufacturing environment, with a strong preference for experience in the medical device industry.
• Knowledge of plastic injection molding processes is highly desirable.
• Certification as a Certified Quality Manager (QM) or Certified Quality Engineer (QE) is required. Additional certifications in Lean, Six Sigma, or ASQ would be advantageous.
• Proficient in using Minitab for statistical analysis, with a deep understanding of metrology principles and calibration standards. Expertise in QMS systems, process controls, and operational quality requirements, specifically within a regulated environment.
• Strong understanding and working knowledge of ISO 9001, ISO 13485, and FDA 21 CFR Part 820 regulations, with the ability to implement and manage compliance programs. Experience with risk management processes such as pFMEA and control plans is essential.
• Extensive experience in conducting, managing, and closing out internal and external audits, including audits with suppliers and customers. Ability to lead audit teams and ensure compliance with industry regulations.
• Demonstrated organizational and leadership abilities with a proven track record of managing cross-functional teams. Strong interpersonal and communication skills with the ability to influence and collaborate with senior leadership and key stakeholders.
• A solid understanding of statistical methods for process validation and quality improvement.