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Life Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living!
In this pivotal quality role, you'll be at the forefront of driving success for our workstream goals at S+N. You'll own the charge in planning, organising, and managing Quality resources to ensure our new Melton site is fully compliant and ready for seamless business operations.
Your role encompasses comprehensive project management, focusing on quality plans and systems to transfer processes and products from our Hull site to our Melton site. You'll coordinate operations to ensure uninterrupted market supply, foster strong stakeholder relationships, and uphold the highest quality standards. You'll also oversee Quality governance on the design, specification, and validation of the new facility, ensuring compliance with all regulatory requirements for manufacturing spaces, laboratories, and processes.
Sound exciting? We believe so!
What will you be doing?
Project Management
* Schedule and report Quality workstream activities.
* Integrate schedule activities and achievements into the overall program plan.
* Document and manage risks, issues, and dependencies.
* Deliver workstream objectives on time and within budget.
* Provide regular project status updates through dashboards and key metrics.
Facility Design, Specification & Validation
* Establish QA processes for inspection and release at Melton.
* Approve facility/equipment qualification and process validation.
* Ensure manufacturing spaces comply with regulatory standards.
* Prepare for facility quality audits.
Budget & Resource Management
* Manage workstream deliverables within allocated resources, deadlines, and budgets.
* Coordinate budgeting for CapEx and other costs.
Compliance & Safety
* Ensure project compliance with QMS and S+N procedures.
* Lead audit readiness efforts.
* Ensure proper document approvals and training.
What will you need to be successful?
Strong experience in Quality Assurance within the Medical Device or Pharmaceutical Industry, including validation and change control. Good analytical and communication skills, with the ability to manage workloads efficiently to maintain compliance and high standards. Experience with Project Management tools and Auditing is a plus!
You. Unlimited
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
* Inclusion, Diversity and Equity: Committed to welcoming, celebrating, and thriving on diversity. Learn more about Employee Inclusion Groups on our website.
* Your Future: Generous bonuses, pension schemes, share options, and car allowance.
* Work/Life Balance: Flexible vacations, paid holidays, volunteering hours.
* Your Wellbeing: Health plans, income protection, life assurance, and more.
* Flexibility: Hybrid working model for most roles.
* Training: Hands-on, team-customized mentorship programs.
* Extra Perks: Discounts, salary sacrifice schemes, and employee discounts.
Applications
If you're passionate about innovation and meet the criteria, we'd love to hear from you. We are committed to fostering an environment where everyone can reach their potential and are proud ambassadors of Smith & Nephew, our customers, and patients.
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