Software Quality Engineer - Lake Forest, United States - SMS Staffing Inc.

SMS Staffing Inc. Lake Forest, United States

3 weeks ago

Description

Job Description

Job DescriptionSMS Staffing Inc is Hiring Immediately for a skilled Software Quality Engineer Job Title: Software Quality EngineerJob Location: Lake Forest, IL, U.S.A OR one of the CA locationsJob Type: Contract (possible extension or convert to hire)Pay: Starts at $47.00 an hourShift Structure: ONSITE, 8:00 AM - 5:00 PM, Monday to Friday, 40 hours per weekThe role of the Software Quality Engineer: The Software Quality Engineer will be based in IL OR California and will be responsible for providing technical, documentation, and implementation support for our Systems and applications.

Effectively assess regulatory and validation requirements for computer systems within organization
Identify and develop all required computer system validation deliverables including but not limited to validation plan, user and functional requirements, regulatory requirements, test strategy, IQ/OQ, deployment plan, traceability matrix, validation summary and others
Ensures compliance to all relevant Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.
- Experience in ISO13495, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer System Assurance
Provide verification/validation activities project estimates per the department operating procedures.
Develop, own and execute to well defined timeline and project plan
Manage compliance, deliverables/templates and ensuring timely completion
- Responsible to maintain a compliance and consistency across teams and projects across sites
- Ensure compliance through corporate level policies, supporting tools and training
Create, develop, and report metrics on the ongoing and pipeline projects
Provide support for external and internal audit activities, including audit process expertise, information repository sources, and inspection readiness including the audit lifecycle process
Coordinate Cybersecurity and Data Integrity actions for sites
- Identify gaps and actions with milestones
- Ensure all milestones are achieved on time
- Establish and execute to the escalation process for issues and concerns
Help plan and execute Lean Process Projects, as assigned, across multiple sites.

About the Software Quality Engineer:The ideal candidate will have the following skills and experience:

Bachelor degree in Computer Science, Information Technology, Healthcare Technology, Life Sciences, or related discipline. Knowledge of regulations and standards that affect the healthcare industry.
5+ years combined experience in software development, validation, and/or quality systems in a regulated environment.
Experience in leading software validation efforts, providing software quality assurance support, providing quality system support to IT systems in GxP quality systems for IT, Pharma, or Device industry.
Experience with writing & executing all computer system validation deliverables
Ability to work on multiple projects and timelines concurrently in a global team set-up
Proven expertise in problem solving and identifying solutions in regulated environment
Ability to work in matrixed environment
Strong organizational and follow-up skills, as well as attention to detail
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Come join the SMS team It takes more than top-notch facilities, modern equipment, and innovative technologies to become our customer's most trusted supplier. It takes people who are committed to our customer's success and who are willing to go the extra mile to get the job done right.

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