Quality Systems Manager

7 days ago


Dundee, Dundee City, United Kingdom Randstad Delivery (GBS) Full time
{"title": "Quality Systems Manager", "content": "Key Responsibilities
  • Implement and maintain the site's Quality Management System (QMS) to ensure compliance with industry standards.
  • Manage the site's Quality Management Planning processes and oversee Quality Improvement Plans.
  • Ensure the overall validation status of the site, manage the Site Validation Master Plan, and chair the Validation Review Board.
  • Lead the audit process for external entities, including Notified Bodies, Regulatory Agencies, and Customers, from preparation to post-audit follow-up.
  • Provide oversight to the Internal Audit program and Post-Market Surveillance Program through direct management of dedicated team members.
  • Supervise Document and Change Control processes, ensuring compliance with applicable standards.
  • Provide effective leadership to the Quality Systems team, taking full accountability for workload management, setting clear expectations, and promoting a culture of accountability and ownership.
Requirements
  • Education: Degree or equivalent in life sciences or a related field.
  • Experience: 3-5 years of experience in Quality Assurance in a regulated industry, preferably in in-vitro diagnostics (ISO 13485:2016).
  • Proven track record in managing notified body audits and staff management.
Key Skills and Competencies
  • Excellent organizational skills with the ability to manage multiple projects simultaneously.
  • Strong attention to detail, particularly in documenting and analyzing complex quality issues.
  • Outstanding writing and communication skills to effectively convey complex issues.
  • Strong problem-solving and motivational skills.
  • Ability to work independently with little or no supervision and manage tasks in a timely and accurate manner.
  • Ability to interact with all levels of the organization and perform in a fast-paced environment.
  • Proven ability to attract, develop, and manage talent for higher levels of performance.

This role is a fantastic opportunity for an experienced Quality Systems Manager looking to make a significant impact within a dynamic and regulated environment.

", "company": "Randstad Business Support", "location": "Dundee, Scotland"}

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