Principal Quality Systems Engineer

Employer: Johnson & Johnson Vision Care, Inc.

Job Title: Principal Quality Systems Engineer

Job Code: A011.5369

Job Location:Jacksonville, FL

Job Type: Full-Time

Job Duties: Design, implement, and support advanced quality systems for medical device design. Lead and manage the Design Controls, Risk Management, and Human Factors Quality Systems WW including the entire product life cycle from concept to design, development, manufacturing, and obsolescence. Create innovative and simple design quality and reliability engineering systems for new technology, new product launches, on-market support, and overall business needs. Establish and maintain an Application Life Cycle Management system such as Polarion ALM. Own and continuously update the Master Hazards and Harms tables as well as the periodic update and change approval of all Risk Management Files in alignment with the Medical Safety Officer and Regulatory Affairs. Work closely with the Medical Safety Officer, Risk Management peers, and other clinicians and data analytics to evaluate risk for Response Letters to FDA, HHE, and/or QRB planning, documentation, and execution. Ensure appropriate Risk Management and Human Factors Outputs are systematically integrated as Design Inputs for NPD. Plan and provide support for FDA and other governmental or ISO Notified Body inspections conducted at JJVS locations. Serve as company representative on Design Controls, Risk Management, and Human Factors during regulatory inspections. Support activities including actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary. Provide leadership in the design and implementation of world-class R&D quality systems to support the development and risk management of refractive and cataract equipment.

Qualifications

Requirements: Employer will accept a Bachelor's degree in Statistics, Engineering, Operations Research, or related field followed by 8 years of progressive, post-baccalaureate experience in job offered or in a Principal Quality Systems Engineer-related occupation.

This job posting is anticipated to close on 1/22/2025. 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.

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

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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.