Spectrum Vascular
Quality Assurance Manager (Hybrid - Bridgewater, NJ)
Spectrum Vascular, White Plains, New York, United States
Quality Assurance Manager (Hybrid - Bridgewater, NJ)
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Quality Assurance Manager (Hybrid - Bridgewater, NJ)
role at
Spectrum Vascular .
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 and exceptional customer service. The company was formed through the acquisition of a portfolio of trusted products that have been widely used 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 critically ill and pediatric patients. 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 requires a professional who possesses the knowledge and skills necessary to provide direction and guidance in current Good Manufacturing Practice (cGMP) regulations as well as ISO13485 Quality Management Systems in a medical device company. The Manager will coordinate with Regulatory Affairs on complaint management and apply risk management principles.
Role Responsibilities
Work directly with the Contract Manufacturer (CMO) to implement, maintain, and improve procedures and processes ensuring compliance with current regulations, standards, guidance, and industry best practices for medical devices that adhere to cGMP.
Provide quality oversight of various quality functions as assigned (e.g., manufacturing process controls and changes, verification and validation).
Ensure data accuracy and integrity in manufacturing and that effective Quality Management Systems are in place and followed.
Ensure manufacturing is completed according to established SOPs, including the usage and control of raw materials, components, and labels.
Maintain and help improve current quality systems, processes, tools, policies, SOPs, and validations to ensure regulatory compliance.
Serve as the quality system subject‑matter expert for change controls, deviations, CAPAs, and complaints, leading execution to completion.
Work directly with engineering, regulatory affairs, supply chain, manufacturing, and other GMP‑responsible departments to resolve deviations and compliance issues.
Coordinate and review change controls, deviations, CAPAs, and effectiveness checks.
Lead or support CAPA investigations, implementation, effectiveness, and closure.
Execute data analysis and trend monitoring.
Conduct internal audits of company systems to assure regulatory compliance.
Manage the Product Quality Review processes, coordinating cross‑functionally to ensure regulatory requirements are met.
Participate in preparation for and hosting of external audits and FDA inspections in collaboration with the Sr. VP Regulatory Affairs.
Assure periodic Management Review meetings are held to meet regulatory requirements.
Provide comprehensive support for FDA audits and offer global guidance for drug product‑related matters.
Interact with FDA and other regulatory agencies during audits, helping to resolve issues or questions.
Help oversee post‑audit activities and assist in coordinating supplier and internal audits.
Oversee and coordinate all controlled documents, ensuring compliance with cGMP and international policies.
Author and support gap assessments of quality systems and documents.
Maintain document control, regulating access and ensuring timely obsolescence.
Develop training programs and deliver training on GMP, data integrity, good documentation practices, and inspection readiness.
Create, improve, and conduct training as needed.
Train and mentor other staff to perform quality duties.
Role Qualifications
Bachelor's degree in a technical field (e.g., biology, chemistry, engineering) required.
5+ years of proven experience in quality management, preferably in a manufacturing or production environment.
Strong analytical skills with the ability to analyze data and identify trends.
Excellent project management skills with the ability to prioritize tasks and meet deadlines.
Knowledge of quality control methodologies and tools (e.g., Six Sigma, Lean).
Familiarity with regulatory requirements and standards (e.g., ISO, AAMI, FDA, cGMP).
Strong communication skills, both verbal and written.
Attention to detail and a commitment to delivering high‑quality results.
Spectrum Vascular is an Equal Opportunity Employer and is committed to creating a diverse and inclusive company culture. We do not discriminate against candidates or employees because of disability, sex, race, gender identity, sexual orientation, religion, national origin, age, veteran status, or any other protected status under the law.
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Quality Assurance Manager (Hybrid - Bridgewater, NJ)
role at
Spectrum Vascular .
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 and exceptional customer service. The company was formed through the acquisition of a portfolio of trusted products that have been widely used 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 critically ill and pediatric patients. 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 requires a professional who possesses the knowledge and skills necessary to provide direction and guidance in current Good Manufacturing Practice (cGMP) regulations as well as ISO13485 Quality Management Systems in a medical device company. The Manager will coordinate with Regulatory Affairs on complaint management and apply risk management principles.
Role Responsibilities
Work directly with the Contract Manufacturer (CMO) to implement, maintain, and improve procedures and processes ensuring compliance with current regulations, standards, guidance, and industry best practices for medical devices that adhere to cGMP.
Provide quality oversight of various quality functions as assigned (e.g., manufacturing process controls and changes, verification and validation).
Ensure data accuracy and integrity in manufacturing and that effective Quality Management Systems are in place and followed.
Ensure manufacturing is completed according to established SOPs, including the usage and control of raw materials, components, and labels.
Maintain and help improve current quality systems, processes, tools, policies, SOPs, and validations to ensure regulatory compliance.
Serve as the quality system subject‑matter expert for change controls, deviations, CAPAs, and complaints, leading execution to completion.
Work directly with engineering, regulatory affairs, supply chain, manufacturing, and other GMP‑responsible departments to resolve deviations and compliance issues.
Coordinate and review change controls, deviations, CAPAs, and effectiveness checks.
Lead or support CAPA investigations, implementation, effectiveness, and closure.
Execute data analysis and trend monitoring.
Conduct internal audits of company systems to assure regulatory compliance.
Manage the Product Quality Review processes, coordinating cross‑functionally to ensure regulatory requirements are met.
Participate in preparation for and hosting of external audits and FDA inspections in collaboration with the Sr. VP Regulatory Affairs.
Assure periodic Management Review meetings are held to meet regulatory requirements.
Provide comprehensive support for FDA audits and offer global guidance for drug product‑related matters.
Interact with FDA and other regulatory agencies during audits, helping to resolve issues or questions.
Help oversee post‑audit activities and assist in coordinating supplier and internal audits.
Oversee and coordinate all controlled documents, ensuring compliance with cGMP and international policies.
Author and support gap assessments of quality systems and documents.
Maintain document control, regulating access and ensuring timely obsolescence.
Develop training programs and deliver training on GMP, data integrity, good documentation practices, and inspection readiness.
Create, improve, and conduct training as needed.
Train and mentor other staff to perform quality duties.
Role Qualifications
Bachelor's degree in a technical field (e.g., biology, chemistry, engineering) required.
5+ years of proven experience in quality management, preferably in a manufacturing or production environment.
Strong analytical skills with the ability to analyze data and identify trends.
Excellent project management skills with the ability to prioritize tasks and meet deadlines.
Knowledge of quality control methodologies and tools (e.g., Six Sigma, Lean).
Familiarity with regulatory requirements and standards (e.g., ISO, AAMI, FDA, cGMP).
Strong communication skills, both verbal and written.
Attention to detail and a commitment to delivering high‑quality results.
Spectrum Vascular is an Equal Opportunity Employer and is committed to creating a diverse and inclusive company culture. We do not discriminate against candidates or employees because of disability, sex, race, gender identity, sexual orientation, religion, national origin, age, veteran status, or any other protected status under the law.
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