Sr Quality Engineer

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Milpitas, California, United States of America

Job Description:

Johnson & Johnson Surgical Vision is recruiting for an experienced Senior Quality Engineer, located in Milpitas, California, USA.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

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 https://www.jnj.com/medtech

The Senior Quality Engineer will work collaboratively with manufacturing, manufacturing engineering and R&D to ensure quality standards are met across all our product lines manufactured in Milpitas.  The Senior Quality Engineer is responsible for providing guidance on audits of all quality system categories to assess compliance to good manufacturing practices, and equipment engineering systems. This person plans and conducts projects and assignments with technical responsibility.

Key Responsibilities:

• Supports the application of quality engineering and quality compliance in support of demanding projects in the areas of:
  • Supply chain (life cycle engineering, manufacturing, or assembly)
  • New product development / new product introduction / new process introduction
  • Quality systems / business improvement
• Develops standard operating procedures, specifications, and provides technical and validation support.
• Develops and implements projects to achieve governance objectives; tracks progress against schedules; provides timely status reports; and communicates status to management
• Provide support and expertise in the implementation and enforcement of GMP, ISO and FDA requirements
• Provide statistical support and analytical problem solving for manufacturing, technical services, and product development to identify root cause of problems
• Audit and approve manufacturing, quality, and engineering qualification documents for conformance to Johnson & Johnson business practices and departmental procedures
• Support Process Improvement activities
• Support processing of product nonconformances in the manufacturing floor
• Support Nonconformance (NC) and Corrective Action and Preventive Action (CAPA) activities
• Other responsibilities may be assigned and not all responsibilities listed may be assigned

Qualifications
 

Education:

• A minimum of a Bachelor’s or equivalent degree, preferably in Engineering or a Science related field.

Experience:

Required:

• A minimum of 4 years of work experience
• Experience in medical device industry with knowledge of 21 CFR 820, ISO 13485
• Computer proficiency with MS Office
• Strong technical understanding of manufacturing equipment and processes
• Experience with GDP and GMP
• Experience with root cause analysis and Corrective Action / Preventive Action (CAPA)
• Experience managing projects and demonstrating project leadership abilities

Preferred:

• Industry experience with capital equipment

 Other:

• CQE Certification is preferred.
• This role is based in Milpitas, California and could require up to 10% domestic and international 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 https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy

 

 

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

Additional Description for Pay Transparency:

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)).

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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits