Sr Quality Systems 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:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Sr Quality Systems Engineer. This position will be located in Santa Clara, CA.

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

This role is responsible for the maintenance and continuous improvement of the Quality Management System and Compliance elements (i.e. Quality Manual, Quality Planning and all associated processes and procedures, CAPAs). This role assists with the development and implementation of processes, procedures, and corrective actions.

Key Responsibilities:

• Assist in developing, administering, and maintaining quality system procedures and activities to ensure that processes and products follow applicable quality standards and regulatory requirements through the coordination of the Quality Management System Change Review Forum. 
• Support and assist with assessment, adoption and integration of Shared Franchise Procedures.
• Assist and support for QMS updates to support market expansion into new markets.
• Prepare for and participate in quality governance and oversight meetings (e.g. Quality Systems Management Review) as assigned.
• Collect, compile, and report monthly quality systems metrics
• Provide support for the management of External Standards Program
• Provide audit readiness support for global health authority and regulatory inspections by coordinating ongoing audit preparation meeting and SME training and providing administrative support and access to audit software tools.
• Support the corrective & preventative actions (CAPA) process and audits as required.
• Performs other related duties as assigned.

Qualifications

Education:

• A minimum of a Bachelor’s degree or equivalent in a Scientific and/or Engineering discipline is required. 

Experience and Skills:

Required:

• 5 years of demonstrated ability in a regulated environment that includes working with ISO 13485 and 14971, GMP guidelines, FDA regulations
• Demonstrated knowledge across aspects of quality systems and quality engineering
• Can provide assist with quality compliance mentoring to business partners
• Confirmed ability to articulate risk and help with critical decisions regarding quality system compliance and product quality
• Proficient communication, presentation, and interpersonal skills

Other:

• This position is on-site in Santa Clara, CA and on-site attendance is required for, at minimum, 3 days a week.

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:

Agility Jumps, Analytical Reasoning, Analytics Dashboards, Coaching, Collaborating, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, System Audits, Systems Analysis

 

 

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