Quality Assurance Manager; Hybrid - Bridgewater, NJ

Quality Assurance Manager (Hybrid - Bridgewater, NJ)

About Spectrum Vascular

Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a
company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics.

This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset.

Role Description

The Quality Manager position will be filled by a professional who possesses knowledge and skills necessary to provide direction and guidance in current Good Manufacturing Practice (cGMP) regulations as well as ISO
13485 Quality Management Systems in a medical device company, including coordination with Regulatory Affairs on complaint management, as well as the application of risk management principles.

Role Responsibilities

Quality Systems:

• The Quality Manager has responsibility for working directly with the Contract Manufacturer (CMO) on the implementation, maintenance and improvement of procedures and processes to ensure compliance with current regulations, standards, guidance and state of the art/ industry best practices for medical devices that adhere to cGMP.
• Quality oversight of various Quality functions as assigned (e.g. Manufacturing Process controls and changes, Verification and Validation)
• Works to assure the quality, accuracy, and integrity of data in manufacturing, to assure that effective and appropriate Quality Management Systems are in place and followed
• Ensures manufacturing are completed according to established SOPs, including usage and control of raw materials, components and labels.
• Maintains and helps improve current quality systems, processes, tools, policies, SOPs and validations to ensure compliance with regulatory requirements.

Deviations, Change Control, CAPAs, and Complaints

• Quality System Subject Matter Expert including leadership and execution to completion of Change Controls, deviations, CAPAs and complaints
• Works directly with Engineering, Regulatory Affairs, Supply Chain, Manufacturing, and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner
• Coordination and review of change controls, deviations, CAPAs, and effectiveness checks
• Leads and/or supports CAPA investigations, implementation, CAPA effectiveness and closure

Audits and Annual Product Reviews, including Management Review

• Conducts internal audits of company systems to assure compliance with regulatory requirements.
• Manages the Product Quality Review processes; coordinating cross functionally to ensure regulatory requirements are met and that actions arising are managed to conclusion.
• Participates in preparation for and hosting of external audits and FDA inspections in collaboration with the Sr. VP Regulatory Affairs.
• Assures periodic Management Review meetings are held to meet regulatory requirements.
• Provides comprehensive support for FDA audits and offers global guidance for drug product-related matters.
• Interacts with representatives from the Food and Drug Administration (FDA) and other regulatory agencies during audits including helping to resolve issues or questions.
• Helps oversee post-audit activities
• Assists in coordination of supplier and internal audits and regulatory authority audits

Document Control

• Provides oversight and coordination of all controlled documents including administrative, technical and production documents.
• Authors and/or supports gap assessments of Quality System and Documents
• Ensures that the Document Control System is maintained including SOPs, methods, production records, change controls, deviations, validation documents, operation manuals, training…