Project Manager, Quality Engineering

We are looking to recruit an experienced manufacturing Project Manager to join our client's team on a permanent basis.

The Project Manager is responsible for the controlled execution of medical device tooling and NPI programmes from customer handover through tooling development, process development, validation, and release to serial production.
The role ensures projects are delivered on time, to cost, and to defined quality and regulatory requirements in compliance with ISO 13485.

KEY JOB RESPONSIBILITIES
Project Planning & Execution
Manage assigned projects from handover through serial production release
Develop and maintain project plans, milestones, and timelines
Ensure adherence to approved NPI phase-gate processes

Cross-Functional Coordination
Coordinate tooling, process development, metrology, quality, operations, and supply chain
Facilitate project meetings and technical reviews
Risk Management & Control
Maintain project risk registers
Identify, assess, and escalate technical, quality, and schedule risks

Tooling & Process Development Oversight
Coordinate tooling design reviews, manufacture, trials, and steel tuning
Support process development and optimisation activities

Validation & Production Release Support
Coordinate IQ/OQ/PQ or PPQ activities
Support FAI and capability studies
Ensure validation approvals prior to production release

Change Control & Configuration Management
Ensure all project changes are formally assessed and approved
Maintain configuration control of drawings and specifications

Customer Communication & Reporting
Act as primary customer contact for assigned programmes
Provide regular project updates and milestone reporting

Documentation & Record Control
Maintain complete and accurate project documentation
Ensure objective evidence is available for audits

Issue Resolution & Escalation

Drive issue resolution and escalate when required
Audit & Compliance Support
Support internal, customer, and regulatory audits

COMPETENCE, SKILLS & EXPERIENCE
Essential:
Medical device project management experience
ISO 13485 knowledge
Injection moulding or tooling exposure
Strong planning and communication skills

Desirable:
Engineering or manufacturing qualification