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 anexperiencedSenior Quality Engineer, located in Milpitas, California, USA.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
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 Bachelors 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.
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 Companys 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 30 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
