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Quality Systems Specialist

1 month ago

Cardiff, Cardiff, United Kingdom ATL Technology Full time
Job Description

We are seeking a highly skilled Quality Systems Specialist to join our team at ATL Technology. As a Quality Systems Specialist, you will play a critical role in ensuring the quality and compliance of our medical devices.

Key Responsibilities:

  • Implement and monitor quality systems processes to ensure compliance with EU and US regulatory requirements.
  • Provide advice and guidance on quality systems procedures and regulatory requirements.
  • Collaborate with design and manufacturing teams to ensure products meet quality and regulatory standards.
  • Develop and maintain quality documentation and records.
  • Conduct internal audits and quality system reviews.

Requirements:

  • Minimum 3 years' experience in a QA/QS environment within the medical device or pharmaceutical industry.
  • Knowledge of ISO13485, Medical Device Directive MDD 93/42/EEC, and FDA QSR Part 820.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.

About Us:

ATL Technology is a fast-growing provider of outsourced design, development, and manufacturing services to the medical device market. We are committed to delivering high-quality products and services that meet the needs of our customers.