Staff Quality Systems Engineer

spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://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://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 communication, presentation, and interpersonal skills.

• Demonstrated experience in leading and/or influencing preferred.

• Certification as an ISO 13485 Lead Auditor preferred.

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 and 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :
$114,000-$197,800
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.