Senior Software Quality Engineer

Johnson & Johnson Innovative Medicine • Jacksonville, FL

2d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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)

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior