Quality & Regulatory Project Manager in Alpharetta Georgia, United States

We are hiring a Q&R Project Manager for our client, a medical devices company. This is an 11-month contract position. The Q&R Project Manager (Medical Device Reporting) provides operational leadership over a project mainly dedicated to improving the processes behind medical device reporting and service order reporting. They are accountable for the development, delivery, and scheduling of the project, in accordance to quality and regulatory demands and compliance requirements.



About this role

Responsibilities

  • Maintains responsibility for planning and organizing resources cross-functionally to achieve global program/project goals and objectives.
  • Develops operating plans and workable business processes for own department in alignment with function strategy.
  • Responds to, solves and makes decisions on business requests that have broader department impact and/or moderate risk.
  • Presents alternative solutions to business issues by leveraging the broader organization.
  • Responsible for own work and contributing to team, department and/or business results. May direct work of non-management staff.
  • Typically influences work of cross-functional or extended teams.
  • Assists Head of PMO and Senior Leadership in achieving business results by:

    - acting in a consultative fashion to implement programs affecting the broader organization.

    - assisting in the development and communication of broader organizational goals.

    - taking calculated risks to move the department or team forward.

    - balancing the interests of own group with the interests of the organization.

    - working with others to identify and remove barriers to success.

    - being a consistent advocate for their own team while holding them accountable for results and high performance

  • Negotiates budgets, resources and timing while creating program/project plans and negotiates team assignments with functional managers.
  • Responsible for establishing and managing the scope, critical path and budget of multiple complex projects at one time.
  • Coach, mentor, manage and develop Program Managers within PMO.
  • Accountable for meeting compliance requirements of external governing authorities, internal Quality Management Systems and Philips business process methodologies (e.g., PEPF, SIM)
  • Collaborates and communicates effectively with teams and utilizes key project management tools (Risk Management Plan, Program/Project Plan, Schedule, Resource Plan, Daily Management, RACIs, etc.) to effectively mitigate risks and provide clear direction.
  • Participate in continuous improvement project teams; determine effectiveness of improvement activities and applicability to own team. Be a catalyst for change.
  • Take a lead role in the recruitment, development and mentoring of talent across the PMO.


About you

Requirements

  • Technical working experience in Projects (or functions) related to the following areas:

    - US FDA and EUMDR regulations on Medical Device Reporting and Post Market Surveillance.

    - Quality Management Systems in a large, complex matrix organization

  • Proven expertise in navigating complex issues utilizing LEAN tools (Most importantly: Obeya Rooms, Daily Management, Kaizen, Value Stream Mapping, Root Cause Analysis)
  • 5- 8 years of experience with advanced levels of project management principles.
  • 5- 8 years of direct work experience in an application development project management/program management environment
  • Strong ability to manage projects remotely, with teams located in various sites and/or countries
  • A bachelors degree in business administration, engineering, supply chain operations, Quality Management or a related field. Comparable business experience to a bachelors degree will also be considered for exceptional candidates, at hiring managers discretion.
  • Familiarity with Quality Management Systems (QMS), Good Documentation Practices, Medical Device Manufacturing
  • Ability to effectively communicate detailed information and strategic decisions, and respond to questions from project stakeholders of all levels, including C-Suite Members
  • Excellent written and verbal communication skills in English Language
  • Ability to draw out organizational/business requirements from and intelligently drive decision making with stakeholders
  • Ability to direct and influence others (whether inside or outside their line of authority) and work within and deliver under rigorous timelines
  • Commitment to sharing information transparently with team members and stakeholders at all levels.
  • Talent to work independently and with minimal supervision while meeting all deliverables (includes working well remotely or in a virtual environment)


What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort let us match you to your ideal position.




About us

Brunel has a reputation for working with some of the best in the business. Thats what we continually strive for. Over 40 years, weve created a global network of interesting clients and talented individuals working together through a vast array of services.

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