drjobs Project Manager

Project Manager

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1 Vacancy
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Job Location drjobs

Irvine - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Responsibilities:
  • Under (e.g. limited supervision general direction etc.) and in accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position.
  • Lead the CIP project by interacting with internal and external stakeholders.
  • CIP calculation starting from getting quotation from supplier.
  • Finalize the budget considering feasibility study capital investment validation expense DVT samples bioburden etc.
  • Create project plan using Microsoft project and power point.
  • Knowledge of product and functionalities.
  • Design change or alternative supplier type projects to achieve type II savings.
  • Different approach to achieve the CIP.
  • Perform testing writing test protocols test reports conduct design review meetings.
  • Understanding on all the project activities time estimation and execution plan.
  • Understanding of what test to perform getting alignment with R&D.
  • Knowledge requirements review process validation.
  • Finalizing RR form review and finalize validation documents.
  • Execution of change request and supplier change requests.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for ensuring subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition.
  • Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures.
  • May supervise/lead and provide technical guidance to lower-level personnel.
  • Performs other duties assigned as needed.
Requirements:
  • Must possess knowledge of theoretical and practical fundamentals and experimental engineering techniques.
  • Knowledge on Quality Management and its tools & techniques.
  • Knowledge about FDA 21CFR211 & 820 ISO 13485 ISO 14971 ISO 17025 and compliance regulations.
  • Knowledge on Medical Device Regulatory Standards MDD and MDR.
  • Knowledge of statistics and Minitab.
  • Knowledge of SolidWorks / CAD to perform changes and revise drawings.
  • Have first-hand knowledge/experience in creating process flow map developing project plan using MS Project Gantts Organize and Manage individual project plan/schedule.
  • Six Sigma Certified preferred.
  • Knowledge on Plastic Moulding Supplier Management Packaging Labelling 510k submission Project Risk Management Verification and Validation.
  • Presentation to Senior Management.
  • Excellent Interpersonal / communication skills Organizational / planning and Project management skills.
  • Understanding of Marketing & market research strategies.
  • Personal computer skills Microsoft Project Windows: word processing project planning presentation e-mail web browsers & spreadsheet software.
  • Take part in making decisions on selection of suitable team based on the project needs in concurrence with the customer.
  • Meet delivery promise in terms of budget and timescales.
  • Monitor project progress and team performance and make necessary changes to the team as needed to ensure achievement of project goals.
  • Work within a multi-discipline team.
  • Liaison with customer designated point of contact and functional area point of contact.
  • Responsibility for team and cross-functional communications; lead phase and business reviews project meeting minutes issues log metrics and other key communications.
  • Progression to management of larger and more complex.
  • Six Sigma R&D PMP PDP IBP FDA Power Point Presentation Strong communication skills ISO 13485 ISO 14971 Medical Device Regulatory Standards Quality Compliance.

Employment Type

Full Time

Company Industry

About Company

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