Senior Quality Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

Job Sub Function:

Job Category:

All Job Posting Locations:

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 Bachelors 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 .

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

Additional Description for Pay Transparency:

Senior IC