Staff Eng Quality Engineering

Johnson & Johnson•Irvine, CA

2d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/medtech At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Requirements

Bachelor's Degree in Engineering or equivalent related field
10 years of experience in related field, automative or medical industry

Nice To Haves

Master's Degree

Responsibilities

As part of New Product Development team, contribute to development activities, including design verification test, process validations, and quality processes.
Serve as subject matter expert on quality lifecycle management and related Quality tools.
Responsible for revision/approval of engineering drawings for both device components and Tool/Jig/equipment, correct application of GD&T, stack up analysis, etc.
Develop and establish effective quality control and associated risk management plans.
Support all Quality Engineering activities for the Life Cycle Management function, including Cost Improvement Projects (CIPs) and Component Qualification activities.
Ensure compliance with the internal quality system policies and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other standards as applicable to medical devices.
Contribute to quality and process activities for Reliability, Risk Management, Analytics/statistical techniques, Requirements Management, and Verification & Validation.
Lead quality improvement efforts for legacy products, continuous improvement, and customer satisfaction.
Design or redesign mechanical and thermal devices or subsystems, using computer-aided design, and develop and test prototypes.
Write, review, and/or approve process and product validation protocols and reports, equipment qualifications, and engineering change orders.
Use statistical tools to analyze data, make acceptance decisions, and improve process capability, with Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.
Direct Failure Mode and Effects Analysis (FMEA) activities for both Design and Process risk assessments.
Knowledge of plastics, mold design, and molding/extrusion processes that allows the quality team to proactively identify potential issues in material selection, component design (DFM), and process parameters that could cause defects such as warpage, imbalances in multi-cavity molds, flash, voids, warping, undercuts, burrs, dimensions out of specification. SME can then recommend corrective actions and preventative measures, reducing scrap rates and rework.
Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products.
Investigate equipment failures or difficulties to diagnose faulty operation and to recommend remedies.
Participate in Material Review Board (MRB) review of nonconforming product, and recommend disposition and corrective action.
Supporting global suppliers of tooling for purchased plastic parts by conducting thorough tool design reviews, review tool capability runs ensuring deployment of appropriate technology and design and analyzing performance data to align tooling performance with startup and long-term business requirements.

Benefits

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year