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Senior Quality Assurance Specialist

2 months ago

Harleysville, Pennsylvania, United States Medical Components Full time
About the Role

We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at Medical Components. As a key member of our Quality Assurance department, you will play a critical role in ensuring the highest quality standards are met in the development, production, and distribution of our medical devices.

Key Responsibilities
  • Quality Assurance Leadership
    • Develop and implement quality assurance processes and procedures to ensure compliance with regulatory requirements.
    • Lead internal audits and manage the internal audit program to ensure timely completion and effective implementation of corrective actions.
  • Regulatory Compliance
    • Ensure compliance with FDA 21CFR820, ISO 13485, EU MDR, and other relevant regulatory requirements.
    • Manage and approve Device History Records (DHR) and inspection records to support product release.
  • Process Improvement
    • Identify and implement process improvements to enhance quality and efficiency.
    • Develop and maintain Key Performance Indicators (KPIs) to measure quality performance.
  • Collaboration and Communication
    • Collaborate with cross-functional teams, including Engineering, Production, and Materials, to ensure effective quality management.
    • Communicate quality-related information to stakeholders, including management, employees, and external partners.
Requirements
  • Education and Experience
    • Bachelor's degree in engineering, life sciences, or a related field.
    • Minimum 8 years of experience in quality assurance, regulatory compliance, or a related field.
  • Skills and Qualifications
    • Working knowledge of FDA 21CFR820, ISO 13485, EU MDR, and other relevant regulatory requirements.
    • Excellent analytical and problem-solving skills.
    • Effective communication and interpersonal skills.
    • Ability to lead and motivate cross-functional teams.
What We Offer
  • Competitive Compensation and Benefits
  • Opportunities for Professional Growth and Development
  • A Collaborative and Dynamic Work Environment