Quality Engineer - 2406179718W

Description

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Quality Engineer , located in Santa Clara, CA !

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/ .

Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our dedication to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact! For more information, visit www.ethicon.com

The Quality Engineer is 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). Candidates should also have knowledge and experience to support equipment qualifications, process validations, manufacturing/testing requirements, Test Method Validation (TMV), protocol development, and risk management per FDA, ISO 14971, and other applicable medical devices standards.

Key Responsibilities:

• Supports and identifies improvement opportunities for Quality Engineering Supply Chain project plans, key milestones, and objectives, to ensure deliverables are aligned with customer’s operational needs and requirements.

• Independently identifies any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.

• Reviews documentation to ensure outputs adhere to quality, safety, and regulatory compliance requirements.

• Performs and/or reviews verifications/validations/qualifications (TMVs, process validations, IQ/OQ/PQ) for current and new processes.

• Develops product quality plans/protocols/engineering studies in conjunction with other quality or product development team members.

• Creates, updates, and/or reviews risk analyses and FMEA's.

• Supports training of Quality Assurance Specialists and Manufacturing Technicians to GDP, quality processes/procedures, and site-specific safety and industrial hygiene requirements.

• Communicates and escalates in a timely manner, any issues, or concerns uncovered to the next management level.

• Mentors more junior colleagues in techniques, processes, and responsibilities.

Qualifications

Education:

• A minimum of a Bachelor's degree or equivalent in Engineering is required.

Experience and Skills:

Required:

• A minimum 2 years of Quality Engineering experience required.

• A minimum 1 year of experience supporting Med Devices/Med Tech industry required.

• Experience supporting complex electro-mechanical, software-controlled systems for medical applications.

• Experience with risk management (pFMEAs), Validations/Qualifications (TMVs, Process Validations, IQ/OQ/PQ), and Failure Investigations (Root Cause Analysis, CAPAs, Non-Conformances).

• Experience working in a regulated environment in compliance to ISO 13485 and 21 CFR 820.

• Strong interpersonal, organizational, verbal and written communication skills; the ability to collaborate effectively as a team member along with analytical and problem-solving skills.

Preferred:

• An Engineering degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering preferred.

Other:

• This position will be located in Santa Clara, CA site and may require up to 10% domestic or international travel.

• This is a full-time on-site position.

• Occasional evening and weekend work may be required as job duties demand.

• 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.

The anticipated base pay range for the Santa Clara, CA location of this position is $89,000 to $140,185.

• 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)).

• This position is eligible to participate in the Company’s long-term incentive program.

• 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 May 15, 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 .

Primary Location NA-US-California-Santa Clara

Organization Auris Health, Inc. (6267)

Travel Yes, 10 % of the Time

Job Function Quality Engineering

Req ID: 2406179718W