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Quality Assurance Coordinator

2 months ago


Mansfield, Ohio, United States Next Phase Medical Devices, an Arterex Company Full time
Job Overview

Position Title: Quality Assurance Coordinator

Reports to: Quality Control Supervisor

Direct Reports: No

Position Summary:

The Quality Assurance Coordinator is responsible for ensuring that all product documentation is thorough, precise, and adheres to ISO 13485 standards and FDA regulations.

Key Responsibilities:

  • Comprehend, support, and adhere to the Company's Quality Management System.
  • Maintain a tidy and safe working environment.
  • Follow established operating procedures and documented work instructions.
  • Communicate effectively with team members across the organization.
  • Conduct reviews of Device History Records (DHR) for production and returned goods.
  • Inspect product labeling for compliance.
  • Prepare product Certificates of Conformance (C of C) for production and returned goods.
  • Perform final product acceptance prior to shipment to customers.
  • Evaluate sterilization process data and reports for compliance.
  • Identify opportunities for continuous improvement in collaboration with the Supervisor.
  • Engage in special projects as assigned.
  • Perform other duties as required.

Additional Responsibilities:

  • Independently verify work affecting quality and possess the authority to execute these tasks as outlined in the responsibilities section.
  • This job description is not intended to encompass all activities, duties, or responsibilities required of the employee. Responsibilities may change at any time with or without notice.

Qualifications:

  • 3-5 years of experience in a regulated manufacturing environment; experience in an ISO 13485:2016 environment is preferred.
  • Strong mechanical aptitude.
  • Effective oral and written communication skills.
  • Ability to collaborate with others.
  • Attention to detail to meet specified requirements.
  • Excellent organizational skills.
  • Strong verbal communication abilities.
  • Proven problem-solving skills in a cross-functional setting.
  • Ability to manage tasks and time effectively.

Physical Requirements:

This role involves working in an office environment, which includes prolonged periods of sitting at a desk using a computer. It may also require lifting up to 40 pounds and standing or walking throughout the facility.

On-Site Attendance: This position mandates 100% on-site attendance.

Company Overview

NextPhase is dedicated to the design, development, and manufacturing of medical devices. As your partner for outsourcing solutions for low- to medium-volume complex electromechanical and single-use devices, we are committed to delivering high-quality service and continuous improvement throughout the product lifecycle. Our comprehensive range of services includes concept ideation, feasibility analysis, design, development, LEAN-focused manufacturing, assembly, and aftermarket services, as well as sterilization and sterilization management. Our strategic locations enable us to implement best practices in medical device manufacturing.

We understand that our work as a medical device manufacturer significantly impacts patients' lives. Our core values empower our employees to provide optimal medical device solutions, enhancing the quality of life for patients.

We take pride in delivering medical device solutions that contribute to improving patient outcomes.