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Product Quality Assurance Manager

2 months ago

Dundee, Dundee City, United Kingdom Randstad Delivery (GBS) Full time
{"title": "Product Quality Assurance Manager", "description": "Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team in Dundee, Scotland. In this role, you will be responsible for implementing and maintaining the site's Quality Management System (QMS) to ensure compliance with industry standards.

Key Responsibilities
  • QMS Ownership: Take ownership of the site's QMS performance, including monthly KPI collation, analysis, and reporting.
  • Quality Planning: Manage the site's Quality Management Planning processes and oversee Quality Improvement Plans.
  • Validation Oversight: Ensure the overall validation status of the site, manage the Site Validation Master Plan, and chair the Validation Review Board.
  • Audit Management: Lead the audit process for external entities, including Notified Bodies, Regulatory Agencies, and Customers, from preparation to post-audit follow-up.
  • Internal Audits & Surveillance: Provide oversight to the Internal Audit program and Post-Market Surveillance Program through direct management of dedicated team members.
  • Document & Change Control: Supervise Document and Change Control processes, ensuring compliance with applicable standards.
  • Team Leadership: 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.
Skills & 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 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"}