Quality/Manufacturing Engineer

10 Days Old

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.
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.). Seniority level Seniority level Associate Employment type Employment type Contract Job function Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Long Beach, CA $80,000 - $200,000 3 days ago Irvine, CA $176,200 - $220,300 2 weeks ago Long Beach, CA $97,000 - $124,300 12 hours ago Long Beach, CA $105,000 - $130,000 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Location:
Irvine, CA, United States
Category:
Engineering

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