Auris Health, part of the Johnson & Johnson family of companies, is recruiting for a Senior Quality Engineer to be located in Santa Clara, CA.
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.
The Senior Quality Engineer will be responsible for providing quality engineering support 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 environment (FDA, MDD, ISO 13485). Candidate should also have knowledge and experience to support Design for Reliability and Manufacturability (DRM), Design for Six Sigma, Design for Lean Six Sigma, testing requirements like Test Method Validations and test protocol development, and risk management per FDA, ISO 14971, and other applicable medical devices standards.
Key Responsibilities

• Identifies and leads Quality Engineering projects including project plans, key milestones, and objectives, to ensure deliverables are aligned with customer's operational needs and requirements for respective sub-system/product line
• Identifies and leads Quality Engineering non-conformances, risk assessments, investigation, root cause analysis, and implementation of corrective/preventative actions
• Responsible for reviewing documentation to ensure outputs adhere to established quality, safety, and regulatory compliance requirements
• Responsible for reviewing documentation of Verification/Validation/Qualification (TMVs, Process Validations, IQ/OQ/PQ) for current and new processes
• Defines quality strategies for product quality plans/protocols/engineering studies in collaboration with other quality or product development team members for respective sub-system/product line
• Responsible for creating, updating, and/or reviewing risk assessments, risk analysis, and FMEA's
• Establishes 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
• Lead production Material Review Board (MRB) meetings and manage non-conformance tracker for applicable product line(s)
• Support corrective/preventive action teams in resolving production, customer and supplier issues (e.g., nonconformances, CAPA or CAPA activities, audit findings, complaint investigations, etc.)

Education:

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

Experience and Skills: Required

• A minimum of 4 years of experience in a Quality, Manufacturing, or Engineering function
• Previous experience in Medical Devices industry
• Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820
• Experience creating, updating, and reviewing Risk Management documentation (pFMEAs)
• Experience supporting Verification/Validation/Qualification activities and creating, updating, and reviewing related documentation (TMVs, Process Validations, IQ/OQ/PQ)
• Experience with leading Failure Investigations and managing non-conformances and/or CAPAs
• Advanced technical, analytical, and problem-solving skills
• Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member

Preferred:

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

Other:

• This position requires to work fully onsite in Santa Clara, CA site 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.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to attend meetings, observe in labs or the manufacturing area. The employee frequently is required to sit, stand or walk.
• This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

In the Bay Area, the anticipated base pay range for this position is $105,000 to $166,635.
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
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on 5/29/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.