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Senior Quality Assurance Analyst

2 months ago

Harleysville, Pennsylvania, United States Medical Components, Inc. Full time
Position Overview

The Senior Quality Assurance Specialist will play a pivotal role in ensuring that our products meet the highest standards of quality and compliance within the medical device industry. This position requires a strong background in quality assurance processes and a thorough understanding of regulatory requirements.

Key Responsibilities

Training and Leadership: The Senior QA Specialist will mentor and train QA Associates, serving as a crucial link between the QA team and other departments such as Engineering and Production.

Quality Assurance Management: You will oversee quality assurance processes to guarantee that products are developed, manufactured, and distributed in accordance with established organizational policies and regulatory standards.

Essential Duties
  • Review and Approval: Evaluate Device History Records (DHR) and inspection documentation to facilitate product release.
  • Internal Audit Program: Develop and manage the annual internal audit schedule, coordinate audits with relevant departments, and ensure timely completion of audit findings.
  • External Audit Support: Prepare for and coordinate activities related to external audits, ensuring all necessary documentation is in order.
  • Change Control Management: Review and approve Change Control Documents, conducting evaluations for significant changes impacting the Quality Management System.
  • Performance Monitoring: Establish and track Key Performance Indicators (KPIs) to assess quality performance.
  • Non-Conformance Management: Evaluate and approve non-conformance reports and corrective action plans, ensuring effective resolution of quality issues.
  • Documentation Practices: Facilitate adherence to good documentation practices and assist in the development of quality system procedures.
  • Continuous Improvement: Lead initiatives aimed at enhancing quality processes and outcomes.
Qualifications
  • Bachelor's degree in engineering, life sciences, or a related field is preferred.
  • A minimum of 8 years of experience in quality assurance within the medical device or regulated industry.
  • In-depth knowledge of FDA regulations (21CFR820), ISO 13485, and EU MDR.
  • Quality certifications such as ASQ Certified Quality Auditor or Engineer are advantageous.
  • Strong analytical and problem-solving skills, with the ability to make data-driven decisions.
  • Excellent communication and interpersonal skills, capable of collaborating across various functional teams.
About Medical Components, Inc.

Medical Components, Inc. is dedicated to developing and manufacturing innovative vascular access devices and accessories that meet the clinical needs of the medical industry. Our commitment to quality and continuous improvement drives our success in providing superior products that enhance patient care.

Employee Benefits
  • Competitive salary and comprehensive health benefits.
  • 401k plan with company match.
  • Generous paid time off and holiday schedule.
  • Opportunities for professional development and growth.