Project Manager
Apply NowCompany: Tata Consultancy Services
Location: Irvine, CA 92620
Description:
Technical/Functional Skills 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 Molding, Supplier Management, Packaging, Labeling, 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
Experience Required
Strong Experience in Quality Management Systems (QMS).
Experience working in various acquisition, integration, and divestiture activities
Work experience in the Medical Device industry.
Roles & 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
Generic Managerial Skills
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
Salary Range: $95,000-$95,000 a year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
#LI-SP1
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 Molding, Supplier Management, Packaging, Labeling, 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
Experience Required
Strong Experience in Quality Management Systems (QMS).
Experience working in various acquisition, integration, and divestiture activities
Work experience in the Medical Device industry.
Roles & 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
Generic Managerial Skills
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
Salary Range: $95,000-$95,000 a year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
#LI-SP1