Project Manger - Quality
Job Specification: Project Manager (Quality) - Medical Devices
Overview
We are seeking a Quality‑focused Project Manager to lead and coordinate a portfolio of interconnected mini‑projects within the medical device Quality function. This role is ideal for someone with strong process thinking, experience working with Quality and IT systems, and the ability to streamline workflows through system‑based solutions rather than manual effort.
You will work closely with another Project Manager and a process expert within Quality, ensuring consistent cross‑calibration, alignment of deliverables, and smooth integration of multiple smaller projects that collectively form a broader transformation roadmap.
Key Responsibilities
Project Leadership & Delivery
- Manage and deliver a suite of small to medium‑sized Quality projects that interlink like a "jigsaw" to form a cohesive improvement programme.
- Plan, coordinate, and monitor project activities to ensure timely delivery and quality outcomes.
- Work collaboratively with a second Project Manager and Quality process experts to ensure alignment.
Quality Systems & Process Improvement
- Lead projects involving Quality and IT system enhancements, upgrades, or integrations.
- Streamline processes by designing and building system‑driven workflows-reducing human/manual interventions.
- Support cross‑calibration initiatives across Quality teams to ensure standardisation and alignment.
Team Management
- Manage two direct reports within the Quality project team, providing guidance, goal‑setting, and support.
- Ensure team members understand systems, processes, and project priorities.
Stakeholder Engagement
- Work with cross‑functional stakeholders including Quality, IT, Operations, and Process Engineering teams.
- Communicate project status, challenges, and solutions clearly and effectively.
Risk & Issue Management
- Identify risks and dependencies across the interconnected mini‑projects.
- Implement mitigation plans and proactively address issues to maintain project momentum.
Required Skills & Experience
Essential
- Proven experience as a Project Manager, ideally within medical devices, pharma, or another regulated industry.
- Strong understanding of Quality processes and Quality Management Systems (QMS).
- Experience working with or managing IT systems related to Quality-e.g., eQMS, document control systems, CAPA systems.
- Ability to navigate multiple smaller projects and align them into an integrated programme.
- Strong process‑oriented mindset with the ability to design, map, and optimise workflows.
- Excellent communication and stakeholder management skills.
- Experience leading or supervising team members.
Desirable
- Prior involvement in system implementations or system-driven process automation.
- Understanding of cross‑functional calibration within Quality teams.
- Experience in medical device regulatory frameworks (e.g., ISO 13485, FDA 21 CFR Part 820).
- Background in working with both Quality and IT stakeholders simultaneously.
FAQs
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