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.
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 Bachelor27s 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 andon-site attendance is required for, at minimum, 3 days a week.
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 Company27s 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 60 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 60 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
