Quality Assurance Specialist

1 day ago


New Kensington, Pennsylvania, United States BV Staffing Full time

Job Title: Quality Specialist

Job Type: Full-time

Location: Westmoreland Business and Research Park, Upper Burrell Township, PA

Job Summary:

The Quality Specialist will play a critical role in maintaining a robust Quality Management System for a Medical Device manufacturer. This individual will be responsible for ensuring compliance with FDA 21 CFR 820, cGMP, MDR 2017/745, and ISO 13485 requirements.

Key Responsibilities:

  • Support the development and implementation of Quality Management Systems
  • Track and document changes to the Quality System, including process improvements and deviations
  • Conduct regular audits and inspections to ensure compliance with regulatory requirements
  • Investigate and document quality issues, including product defects and process deviations
  • Develop and implement corrective actions to address quality issues
  • Collaborate with cross-functional teams to ensure quality is integrated into all aspects of the business
  • Participate in internal and external audits, including FDA and customer audits
  • Stay up-to-date with regulatory requirements and industry best practices
  • Other Quality-related duties as assigned by Management

Requirements:

  • Bachelor's degree from an accredited university
  • Minimum 2 years of experience in a regulated medical device setting or similar
  • Working knowledge of FDA 21 CFR Part 820 and ISO 13485
  • Strong computer skills, including Microsoft Office
  • Excellent communication and analytical skills
  • Ability to work in a fast-paced environment with multiple priorities
  • Additional skills: Process Improvement, Analyzing Information, Attention to Detail, Thoroughness, Dealing with complexity and controversy


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