Must Have Technical/Functional Skills

• Knowledge on Quality Management and its tools & techniques
• Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations
• Knowledge on Medical Device Regulatory Standards, MDD and MDR
• Knowledge on NC, CAPA, Root Cause Analysis and Audit processes
• Knowledge in Statistics, Risk Management and Design control
• Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
• Experience in creating FMEAs & Writing reports
• Experience in PMS (Post Market Surveillance)
• Experience in PLM Tool (Windchill)
• Good understanding of Design, Drawing and GD&T
• Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
• Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
• Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
  
  

Roles & Responsibilities

• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are:
• Development and review of PDP (Product development Process) deliverables
• Review and approve R&D/Engineering protocol/ reports
• Development of Risk management records (i.e. DFMEA) in collaboration with SMEs
• Support and provide guidance on Validations
• Support Quality Documentation
• Support Root Cause Investigation and closure of NC and CAPA
• Review and approve the Change Orders (CR/ CN)
• Support in Design Enhancement
• Interpret new/ upcoming quality/ regulatory requirements and provide guidance
• Work with cross functional teams and internal teams to create deliverables
• Performs other duties assigned as needed
  
  

Generic Managerial Skills, If any

• Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.
• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
• Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
• Ability to understand and follow complex written procedures is required.
• Ability to function in a team environment and deliver on team objectives is required.
• Ability to make decisions and solve problems while exhibiting situational judgement.
  
  

Salary Range: $90,000-$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.