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Sr. Software Quality Engineer
Requisition ID: 1296180514
Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Software Quality Engineer in Jacksonville, FL.
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
The Sr. Software Quality Engineer will have the following responsibilities:
- Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents.
- Create, review and approve software validation documentation.
- Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews.
- Review and approve internal and vendor software packages and test documentation.
- Prioritize and plan all assigned projects for the software validation department.
- Implement new or changed programs/policies/procedures related to CSV and support SDLC & software validation policies, procedures and processes for computerized systems.
- Facilitate change validation as part of the Change Control Board (CCB) as the SQE representative.
- Lead the Installation Qualification (IQ) of manufacturing lines.
- Support CSV improvement initiatives in manufacturing.
- Champion cross-collaboration across functions, sites and operating companies in the area of CSV.
- Identify and resolve barriers that impede business needs.
- Collaborate with Franchise Quality in the deployment (design, implementation, and post-monitoring) of Quality System initiatives impacting the site that promote the continuous improvement of the Quality System and ensure continuity of the application of globally shared processes and systems at the site level.
- Support compliance activities by participating in audit readiness, support internal and external audits pertaining to CSV.
- Serve as the Subject Matter Expert for CSV and manage investigations, responses, and remediation of site-specific CSV audit observations
- A minimum of a Bachelor’s Degree is required, preferably in Engineering, Computer Science or a related technical field.
- A minimum of 4 years of experience in a regulated environment is required.
- Working knowledge of FDA and European medical device regulations (QSR and ISO) is required.
- Working knowledge of software validation requirements for software used in the production of medical devices and software used to support the Quality System is required.
- Working knowledge of GAMP5 and SDLC is required.
- Working knowledge of regulations for electronic records, electronic signatures, and data integrity is required
- Experience with change management and a strength with technical writing is required.
- Experience with SCADA and/or Manufacturing Execution Systems (MES) and experience working in manufacturing/operations is required.
- Medical device process validation experience is preferred.
- Experience in Quality Auditing and notified body inspections is preferred.
- Experience in Quality Systems process development, support, integration or enhancement is preferred.
- Experience with training or coaching others is preferred.
- Software Quality Engineer certification (CSQE) or Quality Engineer certification (CQE) is preferred.
- This position will be based in Jacksonville, FL and requires up to 10% travel (international and domestic).
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Johnson & Johnson Vision Care, Inc. (6094)