Quality Assurance Manager

7 days ago

Columbia, South Carolina, United States Barrington James Full time
Quality Assurance Manager Job Description

Barrington James is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our medical device products.

Key Responsibilities:
  • Lead Quality Assurance Efforts: Develop and implement quality management systems to ensure compliance with regulatory requirements.
  • Regulatory Compliance: Ensure compliance with FDA regulations, ISO 13485, and other applicable regulations.
  • Internal and External Audits: Prepare for and lead internal audits and external regulatory inspections.
  • CAPA Management: Oversee the CAPA system to ensure timely investigation and resolution of quality issues.
  • Document Control: Maintain up-to-date documentation of all quality processes and procedures.
  • Risk Management: Drive risk management processes in accordance with ISO 14971.
  • Supplier Quality Management: Lead supplier qualification and audits.
  • Team Leadership: Manage, mentor, and grow the QA team.
  • Product Lifecycle Support: Collaborate with R&D, manufacturing, and regulatory teams to ensure quality is embedded throughout the product lifecycle.
  • Continuous Improvement Initiatives: Lead quality improvement initiatives using lean methodologies and Six Sigma.
Qualifications and Requirements:
  • Bachelor's degree in Engineering, Quality Management, or a related field.
  • 5-7 years of experience in quality assurance within the medical device industry.
  • In-depth knowledge of FDA regulations, ISO 13485, and other global regulatory requirements.
  • Proven experience leading regulatory inspections, audits, and certification processes.
  • Strong background in CAPA, risk management, and implementing quality systems.
  • Demonstrated leadership abilities, with a track record of managing and scaling quality teams.
  • Certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Six Sigma (Black/Green Belt) are highly desirable.
Work Environment:

This is an on-site role, requiring the candidate to work at our facility alongside key stakeholders from operations, engineering, and quality teams.

Why Join Us?
  • Growth Opportunities: Be part of a fast-growing company with significant career advancement potential.
  • Competitive Compensation: We offer a competitive salary, comprehensive benefits, and opportunities for professional development.
  • Innovative Work Culture: Join a forward-thinking, collaborative team dedicated to improving patient outcomes through cutting-edge medical technologies.
  • Impactful Role: As the Quality Assurance Manager, you will play a pivotal role in shaping the quality and success of our expanding portfolio of medical devices.

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