Staff 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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

San Jose, California, United States of America, Santa Clara, California, United States of America

Job Description:

We are searching for the best talent for a Staff Quality Systems Engineer to be located in Santa Clara or San Jose, CA.

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.

Purpose: This role requires a Quality Engineer with diverse experience. Not only will this individual be responsible for helping govern the overall Quality Management System and the maintenance and continuous improvement of Quality Management System elements this individual will work with the Center of excellence to champion the non-product software processes and support NPS for shared applications sushi as SAP, Agile, MES and Maximo.  In addition, the successful candidate will oversee Records Management for RAD. They will ensure compliance with the Worldwide Records and Information Management (WWRIM) Enterprise Standards and coordinating the management of records and information throughout their lifecycle with cross functional records coordinators in Legal, Human Resources, EH&S, etc.

You will be responsible for:

• Assist in developing, administering, and maintaining quality system procedures and activities to ensure that processes and products follow applicable quality standards and regulatory requirements.
• Coordinate with other COE team members to improve, implement and maintain policies and procedures supporting the non-product software lifecycle process such as GxP evaluation, validation and change control.
• Provide training, direction, and oversight to cross-functional team members (departmental record coordinators) supporting the WWRIM process.
• Assist in supporting the CAPA process by reviewing and monitoring corrective & preventative actions (CAPA); conduct follow-up activities on action items in a collaborative and efficient manner.
• Responsible for the consistent and correct execution of QS procedures at the site to ensure the quality and compliance of processes and records.
• Provide back-room support for global health authority and regulatory inspections as a Medical Device QMS subject matter expert.
• Examines results from management reviews, third party inspections and internal audits and approves proposed corrective actions.
• Performs other related duties as assigned.

Qualifications/Requirements:

• Bachelor’s degree in engineering or science.
• Advanced Degree in Engineering or Physical Science preferred.
• 8+ years demonstrated ability in a regulated environment working with FDA and EU regulations, ISO 13485 and 14971, IEC 62304 and GMP guidelines.
• 2 years of project or program management experience preferred.
• Demonstrated knowledge across multiple aspects of quality systems and quality engineering.
• Expertise in two or more of the following areas: Non-Product Software Management, Quality Systems, CAPA, Risk Management, and records management.
• Prior software experience (Quality Software or Development).
• Proficiency in analysis tools and techniques (e.g., Hazard Analysis, FMEA, Fault Tree, Pareto diagrams, cause-and-effect diagrams, 5 why’s, etc.).
• Can provide compliance mentoring to business partners.
• Strong Project Management Skills.
• Confirmed ability to articulate risk and make critical decisions regarding quality system compliance and product quality.
• Outstanding communication, presentation, and interpersonal skills.
• Confirmed ability to articulate risk and help with critical decisions regarding quality system compliance and product quality.
• Proficient c