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Senior Software Quality Engineer #1140

Company: Medical Engineering Consultants
Location: Jacksonville
Posted on: January 16, 2022

Job Description:

The Senior Software Quality Engineering (SQE) Consultant will be responsible for providing software quality and validation support for our client's SAP Fusion systems and related interfaces.

Perform software periodic reviews for GXP software in the following areas:
a. IT software applications
b. Computerized Laboratory instruments and systems
c. Automated manufacturing lines and related systems
Partners with clients to provide guidance based on compliance with global regulations, client's standards and procedures, and best industry practices. Reviews /approves software validation documentation:
a. Change Requests (CRs)
b. Compliance Analysis
c. Validation / Compliance Plans
d. User Requirement Specifications, User Stories, and Use Cases
e. Functional Requirements Specifications
f. Technical Design Specifications
g. Code Reviews
h. Test scripts for Unit testing, System testing, UAT, etc
i. Testing defects / deviations
j. Risk Analysis
k. Traceability Matrix
l. Validation / Compliance Reports
Provide Quality Assurance support to any validation remediation activities for GXP computerized systems
Partner with testers to ensure all proposed software changes are tested thoroughly and appropriately before approval and issuance
Review and approve change requests and software validation documentation
Ensure all software validation and change control activities are executed and documented in compliance with regulatory requirements and meeting all customer and business needs
Partners with internal clients to ensure compliance with GxP computer systems lifecycle procedures, tools, and methodology.
Supports the resolution of testing deviations / defects, including root cause analysis, corrective action implementation and testing, and proper documentation of all associated activities.
Adheres to environmental and safety policies and procedures and supports department's safety and environmental objectives.

Bachelor's degree in a technical program such as Engineering, Computer Science, or Software Engineering. Advanced coursework in technical systems or continued education in technical disciplines is a plus
Master's Degree preferred - Engineering, Computer Science, Software Engineering
Minimum 4 years work experience in Software Validation within the Medical Device and/or Biopharmaceutical industries
Previous experience working with software validation and compliance activities in a GXP regulated medical device / biopharmaceutical environment; in one or more of these areas:
Manufacturing automation (i.e., PLC-controlled automated lines, machine vision systems)
Computerized laboratory instruments (i.e., HPLCs, GCs)
IT Enterprise software (i.e., LIMS, MES, ERP)
Ability to work within a global team and handle multiple priorities effectively
Knowledge of Systems Development Lifecycle (SDLC) as it applies to computer software for FDA regulated industry
Thorough knowledge of US 21 CFR Part 820 and 21 CFR Part 11 regulations, ISO13485, EU Annex 11, FDA and international Data Integrity Guidelines, and FDA's General Principles of Software Validation
Excellent understanding and application of principles, concepts and practices of Risk Management, Validation, Root Cause Analysis/Failure Investigation.
Excellent written and verbal communication, interpersonal, conflict management, and organization skills
Expertise with Agile and Waterfall software development & testing methodologies.

Experience performing computerized systems periodic validation reviews in GXP regulated industry
Knowledge of Corrective and Preventive Actions (CAPAs) in FDA regulated industry
Knowledge of automated testing tools (i.e., HP Applications Lifecycle Management, JIRA XRay)
ISTQB Foundation (CTFL) or Advanced (CTAL) certification
ASQ CSQE certification.

*Sponsorship/ Corp to Corp is not available for this position.
Check us out at www.medicalengineeringconsultants.com

Keywords: Medical Engineering Consultants, Jacksonville , Senior Software Quality Engineer #1140, IT / Software / Systems , Jacksonville, Florida

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