Sr Quality Systems Engineer

Johnson & Johnson Innovative Medicine • Santa Clara, CA

3d • $109,000 - $174,800 • Hybrid

About The Position

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.

Requirements

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

Nice To Haves

• 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

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.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior