Quality Systems Manager (Medical) - Coleraine or Comber

Job Description

VANRATH are delighted to be assisting a global leader in Healthcare / Medical with the recruitment of a Quality Systems Manager. Fantastic company to work in.

Office is based in either Coleraine or Comber - Monday to Friday

Initially a 12-month contract

This is an Amazing company that has a top reputation.

Salary

Negotiable + Bonus & Fantastic Benefits

About the Role:

The Quality System Manager plays a key role in the success of EHG's Quality Strategy, ensuring the development and implementation of the Quality Assurance strategy while reporting on all aspects of the

Key Responsibilities:

  • · Chair and facilitate the Group Change Control Program, in line with business procedural requirements

· Support New Product Development activities as required

· Lead & Professionally represent at all external agency & customer inspections

· In conjunction with the Quality & Regulatory Department, provide input, support and collaborative decisions regarding the execution of any Field Safety Corrective Actions (FSCA) in a timely, thorough and transparent manner

· Deliver relevant Internal quality assurance training for departments

· As a member of the Group Operations Compliance Team, develop and implement a system for imbedding QA culture through the UK Businesses

· Responsible for ensuring the Quality Management System is maintained to deliver compliance and aligns with assigned KPI

· Support both the Internal and Supplier audit schedule, conducting Inspections when assigned

· Work on cross functional teams providing input when required

· Contribute to budget preparations in conjunction with Head of Group Operations Compliance

· Ensure that all assigned budgets are monitored and delivered

· Measure and trend Documentation and Change Control Programs against agreed

Key Attributes:

· Significant experience in a Quality Engineer role

· Quality Compliance experience in a Medical Device customer driven environment

· Experience in Medical Device or IVD environment working to ISO Standards and FDA CFR in a continuous improvement environment

· Significantly strong communication skills, both verbal and written,

· An organised individual who has the ability to assess priorities based upon the wider business demands

For more information or to apply, please use the link provided or contact Jack Groves.