Senior Quality Engineer

Johnson & Johnson Innovative Medicine•Jacksonville, FL

23h•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, determining methods and techniques to be used, and coordinating phases of work internally and externally. Johnson & Johnson believes health is everything, leveraging healthcare innovation to prevent, treat, and cure complex diseases, deliver smarter and less invasive treatments, and provide personal solutions. Through expertise in Innovative Medicine and MedTech, the company aims to innovate across the full spectrum of healthcare solutions to deliver future breakthroughs and profoundly impact health for humanity. The company is responsible to its employees globally, providing an inclusive work environment that respects diversity and dignity.

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

Eligible to participate in the Company’s consolidated retirement plan (pension).
Eligible to participate in the Company’s savings plan (401(k)).
Eligible to participate in the Company’s 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.