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QMS Project Manager

  • Job reference: 921193
  • Location: Inverness, Highlands
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 15/08/2018

OrionGroup are looking for a QMS Project Manager for our multinational medical devices client based in the Highlands, northern Scotland on an initial 9 month contract.

Main Responsibilities of the role

  • Responsible for project management leadership of one or more, cross functional project teams in the execution of implementation of a single platform Enterprise Wide Quality Management System in accordance with Design Control, Quality and Compliance processes.
  • Responsible for managing cross-functional activities against requirements and timelines while meeting project objectives and supporting the team to ensure successful project execution.
  • Lead and serve as the primary contact between cross-functional project teams and senior management, ensuring clear and concise communication.
  • Responsible for prioritizing and tracking the aspects of projects including integrated project plans and resources.
  • Apply standard project management applications, tools and processes.
  • Responsible for negotiating and implementing plans, deliverables and priorities with key internal stakeholders including R&D, Regulatory, Operations/Manufacturing, Quality and Supply Chain through team members and third party vendors.

Project planning to include but not limited to:

  • Project execution (project plan, schedule, timelines and milestones)
  • Alignment of cross functional partners to drive project deliverables
  • Project leadership
  • Vendor Management
  • Coordination of external partners
  • Launch transition
  • Coordination of design control documentation
  • Identifying risks and establishing mitigation and contingency plans,
  • Facilitating team decisions and issue resolution


Desired Experience and Background of successful candidate

  • People Management experience.
  • Project Management experience.
  • Strong ability for mastering complexity and managing performance in a highly dynamic, high intensity and high information flow environment.
  • Strong working knowledge and understanding of medical device regulations; FDA (Food and Drug Administration), ISO (International Organization for Standardization), MDD (Medical Device Directive).
  • Experience of Software Validation
  • Strong negotiation and influencing skills.
  • Project management and reporting experience essential.
  • Bachelor's degree plus some experience in Medical Devices Industry
  • Masters degree plus significant experience (as above), MBA or technical
  • PMP certification highly desirable.
  • Strong working knowledge and understanding of software Validation and Verification.
  • Experience working with third party developers or external partners.
  • Extensive experience of implementing programs
  • Experience of waterfall and agile implementation
  • Strong analytical skills and intellectual curiosity.
  • Strong negotiation and influencing skills.
  • Experience in Quality System Software Validation and Verification
  • Strong communication, reporting and presentation skills


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.