New Product Development (NPD) Quality Engineer II

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 ;br>
Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Irvine, California, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at ;br>
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Johnson & Johnson MedTech | Electrophysiology (formerly known as Biosense Webster Inc.), is recruiting for a NPD Quality Engineer II, located in Irvine, CA.

As Johnson & Johnson Medtech | Electrophysiology, we have one goal - to ensure those with cardiac arrhythmia can live the lives they want. For more than 30 years, we've been the global market leader in the science and technology of cardiac arrythmia treatment. Our suite of innovative solutions means electrophysiologists are empowered to personalize their approaches for patients with effective and reproducible workflows. Together, we're changing what it means to be diagnosed with atrial fibrillation or other cardiac arrhythmias.

The main role of this job opportunity is to provide overall quality assurance support in the execution of select New Product Development project or legacy product engaged in the development or sustenance of Johnson and Johnson Electrophysiology medical device products. Performs ongoing execution of and provides guidance to good manufacturing practices, compliance to internal and external policies and other applicable standards.

You will be responsible for:

• Provides product team support for multitude of new product development activities (e.g. engineering testing, design and process characterization, and other V&V activities)
• Assists in conducting Quality Assurance documentation reviews and audits as needed
• Support execution of risk management activities
• Support development and execution of relevant process development and validation activities (e.g. IQ/OQ/TMV/APQ)
• Utilizes multifaceted industry and process excellence standards in daily quality operations, including, but not limited to, good manufacturing practices (GMP) and Good Documentation Practices (GDP)
• Assists in addressing product or process issues (internally or externally manufactured) or in investigating customer complaints as needed
• Supports handling complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
• Collaborate with cross-functional teams to achieve project team goals and objectives

Qualifications / Requirements:

Education, Skills & Experience:

• A minimum of a bachelor's degree required (preferably in Engineering or related technical field); or a minimum of 2 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
• Ability to develop and implement Quality standards
• Thorough knowledge of Quality systems and processes, including GMP and QSR requirements for medical devices
• Knowledge of new product development design controls, and verification and validation (V&V) tools and methodologies
• Demonstrated problem solving skills
• Competent in using basic documentation applications such as MS Office (Word, Excel, Powerpoint, Outlook), Adobe PDF, etc.
• Ability to multi-task and manage multiple assignments in a timely manner
• Good verbal and written communication skills
• Strong analytical skills

Preferred Skills & Experience:

• Ability to apply project management skills to ensure fulfillment of new product development requirements
• Experience working in both an FDA and European regulatory environment
• Expertise in NPD (New Product Development) process and Design/Process Validation
• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools

• Six Sigma Green/Black Belt Certified
• Knowledge of GD&T (Geometric Dimensioning and Tolerancing)
• Knowledge of statistical analysis tools such as Minitab is a plus

Other:

• This role is based in Irvine, CA on a flexible work arrangement (partial work from home) and requires up to 10% travel

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:
Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

The anticipated base pay range for this position is :
65,000.00 - 104,650

Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. 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)). Employees are eligible for the following time off benefits: o Vacation - up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year o Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.