Manager of Product Quality, Tampa

POSITION SUMMARY

The Manager of Product Quality will develop, implement, maintain, and continually assess Surterra’s product quality program to meet internal company standards and external regulatory and customer requirements.

CORE JOB DUTIES AND RESPONSIBILITIES

• Develop a comprehensive product quality management program (including both quality assurance and quality control) for all of Surterra’s products
• Implement, maintain, and continually assess and improve Surterra’s product quality management program, quality assurance processes, quality control, and internal and regulatory compliance
• Collaborate with Surterra’s leadership team for planning, execution, and oversight of the product quality management program and continuous process improvement
• Define, develop, and implement short-term and long-term strategies, goals, objectives, and tactics relating to quality management
• Develop departmental key performance indicators (KPIs) and analyze for opportunities to optimize performance
• Use incident and Corrective and Preventative Action (CAPA) activities and processes to drive product quality improvements and respond to process, product, and service issues
• Develop, implement, and manage a post market surveillance program to track quality issues in the field
• Build effective partnerships with leadership team and department heads to help drive the business toward achieving company product quality objectives
• Maintain knowledge base of US and international regulations/guidelines for ensuring compliance and providing senior leadership with associated risk assessment and mitigation

JOB SKILLS AND REQUIREMENTS

• 5+ years in quality management, quality assurance, and quality control
• Prior experience developing, implementing, and managing a quality management system.
• Experience in an FDA-regulated industry (including pharmaceuticals, medical devices, or bioprocessing) and aseptic manufacturing is preferred
• Experience with cGMP, cGPL, and/or related compliance programs
• Green belt or black belt trained/certified is preferred
• Ability to work in a fast-paced, changing, and challenging environment
• Analytically and communicatively intelligent
• Focuses simultaneously on short- and long-term goals; ability to identify problems quickly
• Knowledge of customer service, inventory management (including software) and regulatory compliance
• Accurate data-entry and record keeping
• Strong attention to detail, organizational skills and time management abilities
• Ability to pass a background check, including drug testing, to be registered as an employee of a licensed organization in Florida and/or other Surterra geographies
• Comfort with security protocols, including video monitoring and employee tracking.
• An ability to travel up to 25% of the time
• Bachelor’s degree; advanced degree preferred

PHYSICAL REQUIREMENTS

• The ability to perform repetitive techniques accurately and consistently
• The ability to stand for long periods of time, along with frequent bending
• Close vision (clear vision at 20 inches or less)
• Manual dexterity sufficient to reach/handle items, work with fingers
• Ability to lift up to 50 pounds and push up to 100 pounds with assistance
• The ability to move safely over uneven terrain or in confined spaces
• The ability to perform various physical activities, including lifting, standing, and squatting
• The ability to wear personal protective gear during portions of the day

Apply directly: https://surterra.bamboohr.com/jobs/view.php?id=284

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