Spectrum Vascular

Quality Assurance Manager

Spectrum Vascular

full-time

Posted on:

Location Type: Hybrid

Location: Bridgewater • New Jersey • 🇺🇸 United States

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Job Level

Mid-LevelSenior

About the role

  • 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.

Requirements

  • 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.
Benefits
  • Health insurance
  • 401(k)
  • Flexible work arrangements
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
quality managementdata analysischange controlsCAPASOPsvalidationquality control methodologiesSix SigmaLeanregulatory compliance
Soft skills
analytical skillsproject managementcommunication skillsattention to detailmentoringleadershiporganizational skillsproblem-solvingcollaborationtraining