Project Coordinator Consultant - Must Have Medical Device Experience
United States - Remote
Consulting Services – Project Management /
Remote
RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines in Healthcare products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. In addition to early- and mid-stage MedTech companies, we currently work with 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
With over 500 team members globally, providing world-class consulting services in a remote capacity is nothing new for RQM+. We are dedicated to the highest levels of client service and employee satisfaction delivered with empathy, integrity, individual pride and company spirit.
The Project Coordinator will be responsible for interactions with suppliers to ensure assessments have been completed on potential PFAS material issues and that Supplier Change Requests for material changes have been received. In addition, the Project Coordinator will work with the SQE teams to ensure tasks are being completed on schedule, hosting meetings, preparing minutes, following up with task owners as needed, and escalating when delays are anticipated.
Responsibilities:
- Plan, monitor, document, and communicate project status in alignment with the scope of work. Ensure that plans and processes are followed throughout the program and negotiate with key stakeholders should modifications become necessary. Accountable to monitor and manage out of scope items requested by the client and report any additional opportunities to the Project Owner.
- With assistance, successfully manage through high-risk situations and challenging supplier and client conversations to drive toward a successful outcome in alignment with client needs and the overall RQM+ vision, mission, and strategy.
- Listen carefully to the project team, understand client needs (customer satisfaction), and present project updates.
- May act as a leader on increasingly complicated projects in accordance with the RQM+ QMS Project Management System and Project Leader training guidance.
- Handles project assignments to ensure complete client satisfaction, including excellent communication and predictive issues avoidance/resolution. Responsible to understand and proactively manage the level of client satisfaction with the project at any given time.
- Successfully navigates significant supplier and client-facing challenges in sometimes difficult situations.
- Understand the creation and language of the client statement of work.
- Maintain a focus on RQM+ as a business – manage client interactions to balance RQM+ profitability against the quality of our work.
- Ability to balance the needs of the project, resources, and the client expectations not only from a technical perspective, but also from the RQM+ business perspective
Requirements:
- Bachelor’s level degree in engineering or another technical field required, advanced degree preferred
- Min 2 years’ experience in using formal project management methodology, techniques and tools required.
- 2+ years of experience in the medical device industry required.
- Previous consulting experience, preferred
- Demonstrate ability to manage projects
- Experience with Microsoft Project, Visio, and other Project Management tools
- Ability to adapt to new processes, systems, tools, and environments
- Professional communication skills, both verbal and written
- Attention to detail
- Ability to work with others to overcome hurdles.
- Knowledge of contracting, negotiating, and change management
- Ability to develop and deliver presentations, as well as professional written and verbal communication and interpersonal skills.
- Adept at conflict resolution and problem solving.
- Requires willingness to work a flexible schedule and travel at least 25% of the time with spikes as required to ensure customer satisfaction.
Being an industry leader in client support is just the beginning for RQM+. Providing a rewarding place to work is rooted deep in the core values of RQM+. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ applies the “and means more” approach to employment. At RQM+, you are not just another employee, you are a member of the RQM+ family. Make your impact today!
We invite you to submit an application if you have an interest in learning more about our organization and beginning your journey as a consultant with us.
We require willingness to work a flexible schedule and travel at least 25% of the time
