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:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

Johnson & Johnson Vision Care, a member of Johnson & Johnson Family of Companies, is currently seeking a Sr. Software Quality Engineer, to join our outstanding team located in Jacksonville, FL!

In this role the Sr. Software Quality Engineer applies tools and practices for the effective and efficient development, transfer, and maintenance of manufacturing processes throughout the product lifecycle.

The Sr. Software Quality Engineer conducts assignments encompassing complete projects or portions of major projects. By determining methods and techniques to be used, will coordinate phases of work internally and externally.

Key Responsibilities:

• Support Computer Software Validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents.
• Review and approve software validation documentation, such as qualification protocols, reports, software test scripts, risk analysis, and code reviews.
• Work multi-functionally with Engineering, Operations, R&D and other groups to plan and complete validations on current and new processes for operational integration.
• Facilitate software changes as part of the Change Control Board (CCB) as the SQE representative.
• Support the Installation Qualification (IQ) of manufacturing lines.
• Support CSV programs / policies / procedures and improvement initiatives for computerized systems.
• Support compliance activities by participating in audit readiness, and internal and external audits pertaining to CSV.
• Support investigations, responses, and remediation of site-specific CSV audit observations.

Qualifications

Education:

• A minimum of a Bachelor’s Degree in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field.

Experience and Skills:

Required:

• A minimum of six (6) years of experience in a regulated environment (Medical Device or Pharmaceutical Industry experience is preferred).
• Working knowledge of software validation requirements for software used in the production of medical devices and software used to support the Quality System
• Working knowledge of FDA and European medical device regulations (QSR and ISO)
• Working knowledge of GAMP5 and SDLC
• Working knowledge of Part 11 regulations for electronic records, electronic signatures, and data integrity
• Experience with SCADA, PLC, HMI, Vision Systems, and/or Manufacturing Execution Systems (MES) and experience working in manufacturing/operations
• Experience with change control
• Effective technical writing and verbal communication skills
• Knowledge of non-conformances, root cause investigations, corrective and preventative actions

Preferred:

• Experience in medical device IQ, OQ, and PQ process validation
• Experience in Quality Auditing and notified body inspections
• Software Quality Engineer certification (CSQE) or Quality Engineer certification (CQE)

Other:

• This position may require up to 10% domestic or international travel.

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.

Required Skills:

Preferred Skills:

Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

The anticipated base pay range for this position is :

$79,000.00 - $127,650.00

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)).
This position is eligible to participate in the Company’s long-term incentive program.
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits