Quality/Manufacturing Engineer

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 areas 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.
• Employees must be able to effectively prioritize and manage multiple activities and responsibilities.
• The 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 jud.

Requirements:

• 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.).