WHK Quality & Regulatory Manager

WHK Quality & Regulatory Manager

Position Title:

WHK Quality & Regulatory Manager
Department:
Quality Assurance / Regulatory Affairs

Location:

Clearwater, Florida
Company: WHK Bio Systems, LLC

Employment Type:

Full-Time (On Site)
Salary Range: $120,000+

WHK Bio Systems is seeking an experienced Quality & Regulatory Manager to lead, maintain, and continuously improve the company’s Quality Management System while supporting organization growth within the medical device, life science, biopharmaceutical, and cell & gene therapy markets.

The Quality & Regulatory Manager is responsible for ensuring compliance with ISO 13485, FDA requirements, customer specifications, and internal quality standards. This individual will serve as the company’s primary quality leader and will oversee quality assurance, regulatory compliance, supplier quality, audit management, risk management, validation support, and continuous improvement initiatives.

As WHK continues to expand, this position will play a critical role in strengthening quality systems, enhancing cleanroom quality programs, supporting contamination control initiatives, developing environmental monitoring and bioburden programs, and assisting with future sterility assurance activities as customer requirements evolve.

• Maintain and continuously improve WHK’s ISO 13485 Quality Management System.
• Ensure compliance with ISO 13485, FDA regulations, customer requirements, and internal procedures.
• Manage document control systems, training systems, quality records, and documentation.
• Lead Management Review activities and quality performance reporting.
• Establish and monitor quality objectives and key performance indicators.
• Identify opportunities for continuous improvement and implement sustainable solutions.
• Ensure audit readiness at all times.
• Lead internal, supplier, customer, and ISO certification audits.
• Serve as primary company representative during external audits and inspections.
• Manage responses to audit findings and ensure timely closure of corrective actions.
• Support FDA inspection readiness and regulatory compliance initiatives.
• Coordinate customer quality surveys, supplier questionnaires, and regulatory documentation requests.
• Monitor and communicate changes in applicable quality and regulatory requirements.
• Manage CAPA programs and lead root cause investigations.
• Oversee non-conforming material investigations and disposition activities.
• Manage customer complaints and internal quality investigations.
• Monitor quality trends and implement corrective actions to prevent recurrence.
• Verify effectiveness of corrective actions and ensure timely closure.
• Support production operations involving cleanroom assembly, injection molding, overmolding, tubing assemblies, packaging, and related manufacturing processes.
• Review and approve inspection methods, acceptance criteria, quality plans, and production documentation.
• Participate in new product introductions, process changes, tooling changes, and customer-driven change controls.
• Support process validation and manufacturing qualification activities.
• Collaborate with Engineering and Operations to improve product quality and manufacturing performance.
• Promote a proactive quality culture focused on prevention and continuous improvement.
• Support and oversee quality activities associated with ISO Class 7 cleanroom operations.
• Maintain and improve contamination control programs and cleanroom quality systems.
• Support environmental monitoring programs and bioburden testing programs.
• Support cleanroom certification, recertification, and validation activities.
• Participate in investigations involving environmental excursions or contamination events.
• Support customer cleanliness and contamination control requirements.
• Assist with future sterility assurance initiatives as customer requirements evolve.
• Coordinate with outside laboratories, consultants, and customers regarding microbiological testing and environmental monitoring requirements.
• Manage supplier qualification and monitoring activities.
• Support supplier audits and supplier corrective action programs.
• Review supplier quality documentation and certificates of analysis.
• Partner…