<p>Technical/Functional Skills</p> <ul> <li>GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs </li><li>Strong creative, analytical and problem-solving skills. </li><li>Proficient at interpreting data and putting that data into a report </li><li>Proficient at statistical analysis </li><li>Root Cause Analysis </li><li>Strong CAD Skills (Preferred Auto CAD and Solidworks) </li><li>Strong Fixture design skills </li><li>Experience in creating FMEAs & Writing reports </li><li>Experience in PMS (Post Market Surveillance) </li><li>Experience in PLM Tool (Windchill) </li><li>Process experience, ability to observe and understand manufacturing processes </li><li>Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred </li><li>Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software </li><li>Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.) </li></ul> <p>Roles & Responsibilities</p> <p>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:</p> <ul> <li>Investigate field return products </li><li>Perform root cause analysis on field returned products </li><li>Manufacturing process optimization </li><li>Work with stakeholders to reduce scrap </li><li>Explore process improvement opportunities and support in implementation </li><li>Support in Design Enhancement </li><li>Work in a cross-functional team environment, working with engineering, manufacturing, marketing and suppliers </li><li>Creation of ECOs to upload documentation changes to PLM system (Windchill) </li><li>Know & follow policies & procedures related to work activities performed </li></ul> <p>in area of responsibility</p> <ul> <li>Complete training in area of responsibility within allowed time-period and periodic retraining in areas </li></ul> <p>Generic Managerial Skills, If any</p> <ul> <li>Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language. </li><li>Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. </li><li>Employee must be able to effectively prioritize and manage multiple activities and responsibilities. </li><li>Ability to understand and follow complex written procedures is required. </li><li>Ability to function in a team environment and deliver on team objectives is required. </li><li>Ability to make decisions and solve problems while exhibiting situational judgement. </li></ul> <p>Salary Range: $85,000-$90,000 a year</p> <p>TCS Employee Benefits Summary:</p> <p>Discretionary Annual Incentive.</p> <p>Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.</p> <p>Family Support: Maternal & Parental Leaves.</p> <p>Insurance Options: Auto & Home Insurance, Identity Theft Protection.</p> <p>Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.</p> <p>Time Off: Vacation, Time Off, Si ck Leave & Holidays.</p> <p>Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.</p> <p>#LI-SP1</p>