Senior Quality Engineer

Johnson & Johnson•Jacksonville, FL

1d•Onsite

About The Position

At Johnson & Johnson Vision Care, a member of Johnson & Johnson Family of Companies, 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. This role involves conducting assignments encompassing complete projects or portions of major projects. The individual will determine methods and techniques to be used, and coordinate phases of work internally and externally. The position is located in Jacksonville, FL.

Requirements

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

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year