Technical/Functional Skills

• GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs

• Strong creative, analytical and problem-solving skills.

• Proficient at interpreting data and putting that data into a report

• Proficient at statistical analysis

• Root Cause Analysis

• Strong CAD Skills (Preferred Auto CAD and Solidworks)

• Strong Fixture design skills

• Experience in creating FMEAs & Writing reports

• Experience in PMS (Post Market Surveillance)

• Experience in PLM Tool (Windchill)

• Process experience, ability to observe and understand manufacturing processes

• 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:

• Investigate field return products

• Perform root cause analysis on field returned products

• Manufacturing process optimization

• Work with stakeholders to reduce scrap

• Explore process improvement opportunities and support in implementation

• Support in Design Enhancement

• Work in a cross-functional team environment, working with engineering, manufacturing, marketing and suppliers

• Creation of ECOs to upload documentation changes to PLM system (Windchill)

• Know & follow policies & procedures related to work activities performed

in area of responsibility

• Complete training in area of responsibility within allowed time-period and periodic retraining in areas

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: $100,000-$110,000 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.

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