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Title: Principal Quality Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Permanent
- Pay rate: 120-130K
- Job Location: Marlboro, MA
- Job# bh12042
- Principal Quality Engineer
- Job Brief: The Principal Quality Engineer will generally own multiple assigned product line and/or Quality System projects and uses both technical and project management skills.
- The Principal Quality Engineer will generally own multiple assigned product line and/or Quality System projects and uses both technical and project management skills to bring these projects to fruition: on time, on budget, and achieving desired results. Primary focus for this role is initially the transition from the European Union Medical Device Directive (MDD) to the European Union Medical Device Regulation (MDR). Role is considered technical in nature and projects will typically have technical aspects that may need to be personally handled to get them completed. This is not a Program Management Role.
- Essential Job Functions
- Accountable to lead/project manage the organization’s effort to become MDR compliant per the approved Gantt Chart.
- Continuous improvement of processes using Lean and Six Sigma tools
- Leading project planning sessions
- Coordinating staff and internal resources
- Managing project progress and adapting work as required
- Ensuring actions/milestones meet deadlines
- Managing relationships with clients and stakeholders
- Overseeing all incoming and outgoing project documentation
- Conducting project reviews and creating detailed status reports for executive staff
- Manage/resolve resource conflicts and update project plan as agreed by Stakeholders.
- Manage cross functional and diverse teams
- Accountable for various QA/RA technical projects that improve product quality or quality system compliance.
- Manages and monitors all deliverables on assigned programs, ensuring the quality and timeliness from each function, and leading all core team meetings and attending sub-team meetings as required.
- Responsible for the creation of project plans (master Gantt chart), monitoring status, and managing risk throughout a project’s life cycle, making project execution decisions in conjunction with Supervisor and functional management.
- Leads the preparation, alignment, and presentation at phase review meetings and develops standardized reports to be utilized by the cross-functional team.
- Develop and communicate high quality, integrated cross-functional plans, analysis, and status reports for assigned projects to senior management.
- Recommends scope, schedule, and resource accommodations when project risks are identified.
- Manages cross-functional resources in conjunction with functional management to ensure key action items are on track.
- Support of internal audit
- Knowledge/Educational Requirements
- BA or B.sc in technology or life sciences. Advanced degrees preferred.
- 5+ years of project/ program management in Medical Device or Diagnostics industry working with class II medical devices inclusive of capital equipment and consumables.
- Experience in program management in a global company interacting with R&D, Operations, Quality, Regulatory and Marketing.
- Advanced training in project management and PMP certified preferred
- Experience applying Lean and Six Sigma tools in continuous improvement projects
- Knowledge of FDA, IEC and UL standards relating to medical devices.
- Process driven, passion to details and ability to drive complex program through timetable and overcome obstacles.
- Excellent interpersonal, organizational as well as verbal and written communication skills
- Strong technical and analytical ability
- Proficiency with Microsoft Windows Office tools and Microsoft Project
Our client is seeking: Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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