Senior Quality 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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

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

Position Summary:

The Senior Operations Quality Engineer will be responsible for providing quality engineering oversight for the manufacture of capital systems. The ideal candidate has experience supporting complex electro-mechanical, software-controlled systems for medical applications. This individual will work with engineering and manufacturing operations teams within the company. This position requires knowledge of medical device regulatory requirements and standards such as ISO 13485, ISO 14971, and 21 CFR 820. Candidate should also have knowledge of and experience with equipment qualifications and process validations (IQ, OQ, PQ), and test method validations.

Key Responsibilities:

• Identifies and leads Quality Engineering projects including defining strategies, project plans, key milestones, and objectives in collaboration with cross-functional partners for respective product line
• Responsible for reviewing documentation to ensure outputs adhere to established quality, safety, and regulatory compliance requirements 
• Provides quality oversight for equipment qualifications, process validations, and test method validations (IQ/OQ/PQ/TMV) for current and new processes
• Provides quality oversight for the development of/revisions to manufacturing and test process instructions
• Responsible for documenting and reviewing risk assessments, risk analysis, and FMEA's 
• Leads production Material Review Board (MRB) meetings and manage non-conformance tracker for applicable product line
• Lead cross‑functional teams to identify, investigate, and resolve production issues arising from non‑conformances, CAPAs, or audit findings
• Supports ongoing training of Quality Assurance Specialists and/or Manufacturing Technicians to Good Documentation Practices and Data Integrity, as well as quality processes/strategies and site-specific policies/procedures
• Assesses and addresses Quality Engineering issues or concerns and escalates, as needed, to the next management level

Qualifications - External

Education:

A minimum of a Bachelor’s degree in Engineering is required. Focus degree in mechanical engineering, electrical engineering, or biomedical engineering is preferred.

Experience and Skills:

Required:

• A minimum of 4 years of experience in a Quality, Manufacturing, or Engineering function supporting production equipment/systems
• Previous experience in Medical Devices industry working in compliance to ISO 13485 and 21 CFR 820
• Experience with Risk Management documentation (such as pFMEAs) and ISO 14971
• Experience with equipment qualifications and process validations (IQ/OQ/PQ), and Test Method Validations (TMVs)
• Experience with leading failure investigations and managing non-conformances and/or CAPAs
• Experience with statistical analysis and process capability assessments 
• Advanced technical, analytical, and problem-solving skills 
• Strong written and verbal communication communication skills, and the ability to work effectively as a team member 
• Attention to detail and commitment to compliance and data integrity
• Collaborative, able to work cross‑functionally and influence without direct authority

    Preferred:

• Experience supporting complex electro-mechanical, software-controlled systems for medical applications 
• Six Sigma Green Belt Certification

    Other:

• This position is fully on-site in Santa Clara, CA, and may require up to 10% domestic or international travel. 
• This is a full-time position that may require occasional evening and weekend work based on business needs. 

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:

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