WHK Quality & Regulatory Manager

QUALITY & REGULATORY MANAGER

Department: Quality Assurance / Regulatory Affairs
Location: Clearwater, Florida
Company: WHK Bio Systems, LLC
Status: Full-Time (On Site)
Salary Range: $120,000+

POSITION SUMMARY

WHK Bio Systems is seeking an experienced Quality & Regulatory Manager to lead, maintain, and continuously improve the company's Quality Management System while supporting the organization's 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 its capabilities and customer base, 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.

The ideal candidate is a hands-on leader who is comfortable working directly with production personnel, engineers, customers, suppliers, auditors, consultants, and executive management.

COMPANY OVERVIEW

WHK Bio Systems is an ISO 13485-certified and FDA-registered contract manufacturer serving the medical device, biopharmaceutical, life science, and cell & gene therapy industries.

WHK specializes in custom single-use assemblies, molded and overmolded components, tubing assemblies, cleanroom device assembly, and contract manufacturing solutions for highly regulated markets.

Operations include ISO Class 7 cleanroom manufacturing, injection molding, overmolding, tubing assembly, RF welding, laser processing, assembly, packaging, machining, and related manufacturing processes.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Quality Management System Leadership

• 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 quality 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 the organization remains audit-ready at all times.

Audit & Regulatory Compliance

• Lead internal audits, supplier audits, customer audits, and ISO certification audits.
• Serve as the 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.

CAPA, Nonconformance & Investigation Management

• Manage Corrective and Preventive Action (CAPA) programs.
• Lead root cause investigations utilizing appropriate quality methodologies and tools.
• Oversee nonconforming 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.

Manufacturing Quality Support

• 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.

Cleanroom, Microbiology & Contamination Control

• Support and oversee quality activities associated with WHK's ISO Class 7 cleanroom operations.
• Maintain and improve contamination control programs and cleanroom quality systems.
• Support environmental monitoring programs, including viable and non-viable particulate monitoring.
• Assist with development and implementation of 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…