Quality and Compliance Lead

We have an exciting mid-shift, Manila-based opportunity for a Quality and Compliance Lead. Work from home or office-based – you choose!

When you join Yempo, you’ll receive the following fantastic benefits:

  • Highly competitive salary – paid weekly!
  • HMO enrollment on commencement
  • Additional HMO dependents are added each year of service
  • 20 vacation days per year; 7 sick days
  • Annual performance bonuses and incentives
  • Annual salary reviews and increases
  • Free cooked rice, snacks and hot drinks
  • Company polo shirts are provided
  • Fantastic, bright and cheerful open-plan work environment
  • Prestigious clients and highly professional and friendly co-workers

Our Client

In this position, you will be assigned to our client in the UK. This healthcare specialist business is focused on developing and implementing technologies and services to reduce the risk of patients, staff, and the public acquiring infection in clinical and non-clinical environments. It is trusted by over 40% of UK National Health Service Trusts.

Your Responsibilities

  • Document Control
    • Ownership of new and existing product Technical Files in line with ISO 9001.
    • Manage documentation version control for internal, public and confidential.
    • Develop a document control system for end-to-end product life ready for future ISO13485 Medical Device certification, including accountability and full traceability.
    • Manage Engineering Change Notifications (ECN) & Non-Conforming Product (NCP) technical document updates.
    • Produce and update work instructions and Visio process flow for R&D and Product documented procedures.
  • Compliance
    • Oversee and manage the existing product portfolio global standards, ensuring new product and existing product Certificate of Conformity adheres to current relevant standards.
    • Supported new market development with product, customer, and country regulatory insights.
    • Engage with market SMEs to understand product, customer and country regulatory requirements.
    • Internal auditor for R&D new product introduction methodology.
    • Create User Manual briefs in line with BS EN IEC 82079-1 Information for Use of Product standard.
    • Provide input to new Product Requirements Document (PRD) on the relevant global standards for the intended use of the latest products and appropriate to the market segment they will operate within.
    • Support with internal and external audits by the Quality & Compliance Lead.
    • Support new product component sourcing to ensure parts adhere to relevant standards and maintain accurate data sheets for product Bill of Materials (BOM).
  • New Product Development Engineering Technical Support
    • Ensure all documentation from R&D and into production is imported into live working technical files and public documentation is published in the SharePoint Hub technical file.
    • Conduct new product risk assessments for users and internal manufacturers.
    • Take technical product information and develop customer-facing Standard Operating Procedures (SOPs).
    • Using technical knowledge of a new system and convert into robust end-user training material.

Your Background

  • Minimum of three years of experience in Quality and Compliance or a similar position
  • Understanding of ISO accreditations, ideally 14001, 9001, 45001 and 27001
  • Understand Risk Management and keeping risk registers up to date
  • Have an understanding of non-conformities and root cause analysis
  • Ideally, they will have worked with an organisation in the UK, but they are not essential
  • Relevant bachelor’s degree qualification
  • Excellent written and verbal English communication skills
  • Highly motivated and confident
  • Time management, organisational and planning skills
  • Ability to learn business context quickly
  • High level of computer competence

Disclaimer for Salary Ranges – Yempo provides an indicative range of salary that we deem relevant for the advertised role. This may be adjusted for the skills and experience of the selected candidate.

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