Spectrum Vascular · 1 month ago
Quality Assurance Manager (Hybrid - Bridgewater, NJ)
Bridgewater, NJ
Full-time
Hybrid
Senior Level
5+ years expSpectrum Vascular is an innovative medical device company focused on vascular access and medication management. The Quality Assurance Manager will provide direction in compliance with cGMP regulations and ISO13485 Quality Management Systems, overseeing quality functions, managing audits, and ensuring effective training programs are in place.
ManufacturingMedical Device
Responsibilities
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
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
Executes data analysis, trending
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
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 documents and any other relevant controlled documents in compliance with cGMPs, and international policies and procedures
Ensures management of documents, including regulating access to controlled documents and obsolescence of documents accordingly
Develops training programs as applicable to ensure organization understands and maintains compliance with the regulations, standards and guidance
Develop and/or delivers training programs, and administration as required, e.g., GMP, data integrity, good documentation practices, and inspection readiness
Helps create, improve and conduct training as needed
Trains and mentors other staff to perform quality duties
Qualification
Required
Bachelor's degree in a technical field (e.g., Biology, Chemistry, Engineering) required
5+ years 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
Company
Spectrum Vascular
Spectrum Vascular's aim is to make patients' lives better all around the world by offering caregivers innovative, high-quality products.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknownKey Investors
SK Capital Partners
2025-03-31Private Equity
2025-03-31Debt Financing
Leadership Team
Sharon Klugewicz
Chief Operating Officer
Recent News
Medical Product Outsourcing
2025-05-03
2025-04-15
Company data provided by crunchbase