Quality Assurance Specialist

4 weeks ago

Brackley, Northamptonshire, United Kingdom SkyeBiz Full time

About SkyeBiz

SkyeBiz is a leading medical device manufacturer dedicated to improving patient care through innovative solutions. Committed to the highest quality and compliance standards, we are seeking a meticulous and detail-oriented Quality Associate with ISO 9001 experience to contribute to our team.

Position Overview

The Quality Associate will play a vital role in supporting our Quality Management System (QMS) to ensure adherence to ISO 9001 standards. This position involves conducting quality assurance activities, assisting with audits, and maintaining documentation to support our medical device manufacturing operations.

Key Responsibilities

  • Support the implementation and maintenance of the QMS in compliance with ISO 9001 standards.
  • Assist with internal and external audits, including preparation of documentation and follow-up on findings.
  • Maintain and manage quality records, documentation, and reports to ensure accuracy and compliance.
  • Conduct quality assurance activities such as inspections, testing, and calibration.
  • Participate in the investigation and resolution of quality issues, nonconformances, and customer complaints.
  • Monitor quality performance metrics and assist in identifying areas for improvement.
  • Collaborate with cross-functional teams, including production, engineering, and R&D, to ensure quality standards are upheld.
  • Provide support in training staff on quality processes and procedures.
  • Contribute to continuous improvement initiatives to enhance product quality and optimize manufacturing processes.
  • Stay updated on industry trends, regulatory changes, and best practices in quality management.

Qualifications

  • Bachelor's degree
  • Strong organizational and documentation skills.
  • Excellent communication and interpersonal abilities.
  • Analytical and problem-solving skills.
  • Proficiency in quality management software and tools.

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