Project Lead (Quality) – Medical Device

Recruiter
Morgan McKinley
Employment Type
Permanent
Salary
Not disclosed
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ABOUT THIS ROLE:

The Quality Project Lead is responsible for leading , organising, managing and control of Quality projects relating to Quality Strategic Programs including Quality Goals & Objectives, Total Quality Improvements, Cost Improvement Programs, Innovation & Automation Initiatives and Value Streams Projects. This is a non people management role but you will have an excellent opportunity to support and drive business projects. There is also Hybrid working on offer with this role.

KEY RESPONSIBILITIES:

  • Leads the cross-functional team and manages the development, roll-out, and implementation of all aspects of set projects.
  • Coordinates all aspects of the project activities and is responsible for overall project success including approval, funding & budget management and FPOs.
  • Responsible for facilitating and developing cross functional project plans, timelines, and resource requirements.
  • Perform project management tasks for small to large scale projects.
  • Determining the budget requirements.
  • Conduct strategic planning with quality function & business unit leaders.
  • Propose options to Management/Customer/Stakeholders.
  • Provide technical support for projects.
  • Utilize necessary project tools, e.g Microsoft Project, etc. to manage projects successfully.
  • Propose and implement improvement projects that improve compliance.
  • ¬≠Manage direct report and assigned project resources.
  • Define root cause and implement solutions to equipment and process related non-conformances utilising the NC and CAPA processes.
  • Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements.
  • Ensure effective closure on quality system documents (Audit Action, NCR’s, CAPA’s, Validation Documents etc.)
  • ¬≠Performs other related duties as assigned by management.

EDUCATION AND REQUIREMENTS:

  • A minimum of a Bachelor’s degree, preferably in Science or Engineering or related technical field.
  • 5-8 years related experience i.e within Quality Operations / continuous improvement / project management
  • Experience working in both an FDA and European regulatory environment is preferred.
  • In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
  • Experience with a proven track record of implementing appropriate risk mitigation.
  • Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
  • The ability to perform “hands on” troubleshooting and problem solving
  • Good technical understanding of manufacturing equipment and processes is required.
  • Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
  • A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
  • Strong mentoring, coaching and leadership skills.
  • Demonstrated project management and project leadership abilities are required.

If you are interested in this opportunity, or if you would like to find out more, reach out to Kellie O’Donovan today on or

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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