Quality Assurance Specialist

2 days ago


Somersworth, New Hampshire, United States Life Science Outsourcing, Inc. Full time
Job Title: 2nd Shift Quality Inspector

Life Science Outsourcing, Inc. is seeking a highly motivated and detail-oriented 2nd Shift Quality Inspector to join our team at our New Hampshire facility in Somersworth. As a Quality Inspector, you will play a critical role in ensuring the quality and compliance of our medical devices.

Key Responsibilities:
  • Conduct quality assurance and quality manufacturing functions, including generating certificates of compliance, inspection and testing, disposition of product, incoming inspection, in-process and final inspection, and review of Device History Records (DHRs).
  • Follow written procedures for testing and accurately document all test data.
  • Communicate test data results and findings that are outside specified limits.
  • Maintain compliance to appropriate US FDA regulations and ISO 13485 Quality Management System standards by following written procedures.
  • Submit and maintain test result documents.
  • Work directly with manufacturing and engineering personnel to test and inspect components and materials.
  • Promote the smooth flow of products through quality control to disposition.
  • Provide test and inspection support to all new process developments.
  • Review Device History Records (DHR) and review all lab results and approve product release.
  • Work in a team environment with all quality control inspection personnel.
Requirements:
  • Attention to detail in a fast-paced environment.
  • Ability to work independently and take initiative.
  • Good interpersonal, communication (both verbal and written) skills.
  • Strong verbal and written communication skills.
  • Excellent organizational skills with the ability to handle multiple projects.
  • Passion for customer service and business growth.
  • Displays courtesy, tact, and patience during interactions with all employees and customers.
  • Confident and creative.
  • Acts in an ethical manner at all times and demands the same in others.
  • Experience in process troubleshooting and timely resolution of issues.
  • Eager to be a team player.
Physical Demands:
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


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