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Job Function:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Jacksonville, Florida, United States of AmericaJob Description:
Johnson & Johnson Vision Care, a member of Johnson & Johnson Family of Companies, is currently seeking a Senior 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 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Skills Required
- A minimum of six years of experience in a regulated environment
- Working knowledge of FDA and European medical device regulations
- Experience with SCADA, PLC, HMI, Vision Systems, and/or MES
- Bachelor's Degree in Engineering, Computer Science or related field
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
