Quality Manager

Quality Manager

The Quality Manager is responsible for driving customer satisfaction and process improvement for a given facility. Key activities include hosting management reviews and customer audits; overseeing the calibration, NCM, CAPA, internal audit and document control systems; and driving compliance with current quality system standards, FDA GMP (Food and Drug Administration Good Manufacturing Practices) and ISO 13485 : 2016.

Primary Responsibilities

• Establishes weekly, monthly and annual objectives to ensure priorities are aligned with organization plans and priorities.
• ISO Management representative; responsible for ensuring certification audits drive process improvement by preparing and distributing management review reports. Schedules and hosts registration and customer audits. Conducts supplier audits as needed.
• Works with local managers to ensure compliance and improvement to established quality system requirements and standards. Reviews new or revised Quality System documentation for acceptance.
• Ensures customer needs related to Quality System activities are met in accordance with the established requirements.
• Develops a high-performance quality team. Teaches, coaches, counsels, disciplines, plans, and evaluates job performance.
• Maintains quality documentation system, collaborates with other members of management in the development of new products and engineering designs and manufacturing and training methods. Ensures documented standards are effective and clearly written. May assist others with the writing and revision of policies, procedures, and work instructions.
• Ensures local and senior managers understand the operations process capability and the customer's quality experience. Activities include collecting, analyzing, and communicating information and trends to Sr. Management.
• Ensures the timely resolution of customer complaints and NCM processes by effectively administering the Corrective and Preventive Action Program (CAPA). Prepares product and process quality reports; collects, analyzes, summarizes and communicates information and trends to Sr. Management.
• Cost Containment / Reduction : Controls operational costs and reduces waste. Recommends improvements that identify and reduce areas of waste.
• Proactively looks at trends and develops action plans or suggestions in a collaborate approach with other functional areas to drive ongoing improvement.
• Works closely with operations and engineering with product and process validation activities.
• Assists in Supplier Management System by qualifying and requalifying suppliers.
• Ensure that all employees in the given location are trained on the quality policy.

Basic Qualifications

Preferred Qualifications

Working Conditions

Special Requirements