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Software Quality Specialist

4 months ago

Clearwater, United States Kelly Science, Engineering, Technology & Telecom Full time

Software Quality Specialist | Contract-To-Hire (Full Benefits)

Clearwater, FL | On-Site

*NO C2C OR THIRD PARTY*


The ideal candidate will have Data Integrity experience and experience writing SOP


Objectives / Purpose of the Job

Support the validation of software for manufacturing processes in a medical device regulated environment.


Key Activities / Responsibilities

Execute Software Quality Assurance activities in compliance with applicable policy and procedures. Assure compliance to all Global Software Quality Assurance initiatives, directives, and procedures. Provide training to respective groups on all Global Software Quality Procedure and their associated templates. Be responsible for the review and approval of all validation project documentation and assurance that the project meets all B+L and regulatory requirements. Some of the Software Quality Assurance activities may include authoring validation plans, assisting in developing test scripts, training the project team in software validation practices as it relates to GMP, reviewing /approving validation documents, following through on critical action items, and supporting the development of validation reports and overall B+L software validation effort.


Qualifications

  • Degree in computer science or related technical degree
  • 13485, ISO 9001, GMPs, MDR required. CMDR, JPAL, ISO 14001, OHSAS 18001, and other regulations are desired.
  • knowledge and experience in a regulated medical device or pharmaceutical industry and experience with managing external agency audits necessary.
  • understanding of 21CFR11 electronic signature and Data Integrity requirements.
  • Certified Software Quality Engineer (CSQE) would be a plus but not a prerequisite. Solid experience with leading project teams by providing guidance and recommending changes.
  • written and oral communication and interpersonal skills.
  • knowledge of PLC, MMI (man / machine interface), SCADA, and machine control systems. Computer & Information Technology Skills including Windows, Word, Excel, Power Point, Project, Visio, statistical software (i.e. Minitab).
  • years hands on experience in automated manufacturing processes. 3+ year's hands-on experience with Software Quality in a GxP environment