The Quality & Regulatory Manager will implement and maintain the Quality System for the Company especially regarding the medical division. In compliance with applicable laws and regulations, the Quality & Regulatory Manager will lead the strategic and operational aspects of the Company’s regulatory program. This position will be responsible for the Quality Control and Quality Assurance functions, manage quality department personnel, and ensure compliance to corporate policies, US FDA, ISO standards, and other applicable federal/state agency and international requirements, as appropriate.

This position reports directly to the CEO and is an important part of the Company’s management team.

Essential Duties of this position:

• Serve as main regulatory correspondent and strategist with FDA, Notified Body/ISO Registrar, other regulatory agencies, partner companies, and service providers.
• Serve as the Quality and Management Representative for the company.
• Supervise Quality Department employees through training, coaching, and counseling; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; monitor and enforce adherence to policies and procedures to ensure compliance and support the needs of the business.
• Ensure compliance with all applicable regulations, standards, systems, procedures and practices (includes Quality System, cGMP, and other regulatory standards as applicable).
• Maintain an up-to-date knowledge of applicable federal and local GMP regulations and guidelines. Act as the technical expert for all regulations (FDA, ISO, etc.) ensuring the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance. Monitor external regulatory developments, identify risks, and communicate potential issues to senior management.
• Responsible for Quality Agreements and input for supplier agreements.
• Provide direction on development and implementation of training programs for direct reports and other functional groups to assure awareness of all quality system requirements and maintain compliance with all current and future regulations.
• Manage controlled documentation creation, approval, modification, and release.
• Review validation and test report protocol development, execution, and final report review to assure that quality requirements are established and achieved.
• Manage supplier quality including qualifications and requalification.
• Generate reports, utilizing statistics, as appropriate, to evaluate trends and to aid management in the identification and resolution of issues and overall quality improvement effort.
• Assist customers with quality and regulatory requirements, including technical file documentation from a manufacturing perspective as appropriate.
• Ensure all procedures and work instructions associated with complaint handling are compliant with internal and external requirements.
• Manage the CAPA system to assure that corrective and preventative actions are appropriately investigated and documented.
• Review CAPAs prior to closure to ensure required actions were completed.
• Assist in the develop of inspection methods, design gauges and fixtures to improve inspection.

Qualifications:

• Bachelors degree in Engineering or related field with experience
• Having experience with ISO 9001 certification is a must
• Experience with FDA regulation is beneficial
• Have worked with ISO 7 cleanroom environment is helpful
• A familiarity with plastic molding is helpful

This position reports directly to the CEO and is an important part of the Company’s management team.

Job Type: Full-time

Pay: $60,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off

Experience:

• ISO 9001: 1 year (Required)

Work Location: In person