30 days old

Software Quality Engineering Consultant (SQE)

Kelly Services
Jacksonville, FL 32232
Kelly Services is partnering with one of our top tier clients in the Medical Device/Bio-pharmaceutical industries.. This opportunity is a contract role with the opportunity to go full time with our client and comes with enhanced benefits including medical, PTO, and Holiday pay.

+ Company will pay half of medical premiums monthly.

+ Shift/ Work Hours: Normal Business hours M-F. (40 hours a week )

+ Pay: $35-$40 per hour.

+ Work Location: 7500 Centurion Pkwy. Jacksonville, Florida 32256

The Software Quality Engineering (SQE) Consultant for SAP will be responsible for providing software quality and validation support for VisionCares Enterprise Resource Management system, FUSION; which is composed of SAP, Webmethods, and interfaces with multiple information systems.

**The SQE Consultant will:**

+ Provide Independent Quality Assurance guidance based on global regulations and J&J standards and procedures,

+ Partner with testers to ensure all proposed software changes are tested thoroughly and appropriately before approval and issuance,

+ Review and approve change requests are software validation documentation,

+ Ensure all software validation and change control activities are executed and documented in compliance with regulatory requirements, global J&J and JJVC requirements, and meeting all customer and business needs.

+ Partners with SAP Leads and IT Risk Management to ensure compliance with GxP computer systems life-cycle 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 departments safety and environmental objectives.


Previous experience working with software validation and compliance activities for SAP ERP in a regulated medical device/bio-pharmaceutical environment.

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 regulated industry.

Knowledge of automated testing tools (i.e. HP Applications Life-cycle Management)

Thorough knowledge of US 21 CFR Part 820 and 21 CFR Part 11 regulations, ISO13485, EU Annex 11, MHRA Data Integrity Guidelines, and FDAs 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.

Highly Desirable:

Expertise with Agile software development methodology

Expertise with automated testing through HP ALM/HP QC

ISTQB Foundation (CTFL) or Advanced (CTAL) certification

ASQ CSQE certification


[80%] Partners with clients to provide guidance based on compliance with global regulations, J&J standards and procedures, and best industry practices. Reviews / approves software validation documentation:

+ Change Requests (CRs)

+ Compliance Analysis

+ Validation/Compliance Plans

+ User Requirement Specifications and Use Cases

+ Functional Requirements Specifications

+ Technical Design Specifications

+ Code Reviews

+ Test scripts for Unit testing, System testing, UAT, etc

+ Testing defects/deviations

+ Risk Analysis

+ Traceability Matrix

+ Validation / Compliance Reports

[20%] Provide Quality Assurance support to any validation remediation activities for SAP.


Minimum education required for competent performance:

+ Bachelor 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.

+ Masters Degree preferred Engineering/ Computer Science

+ Minimum 6 years of work experience in Software Validation within the Medical Device and/or Bio-pharmaceutical industries

+ Minimum 2 years of work experience in Software Validation for SAP

**Why Kelly** **** **?**

At Kelly
Services , we work with the best. Our clients include 95 of the Fortune
100 companies, and more than 70,000 hiring managers rely on Kelly annually to access
the best talent to drive their business forward. If you only make one career connection today, connect
with Kelly.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people
around the world and have a role in connecting thousands more with work through our global network of
talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.


Posted: 2019-07-19 Expires: 2019-08-19

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Software Quality Engineering Consultant (SQE)

Kelly Services
Jacksonville, FL 32232

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