at Spectraforce Technologies Inc. in Highland ParkLake Forest, Illinois, United States
Job Description
Job Title: Software Quality Engineer
Location: Lake Forest, IL and San Diego, CA
Duration: 12 months
Position Summary:
The Software Quality Engineer will be responsible for providing technical, documentation, and implementation support for our Systems and applications.
This position is also expected to understand and exhibit the importance of adhering to regulations (i.e. SOX, FDA, HIPAA, PCI, etc.) and is responsible for contributing to regulatory compliance.
The role is expected to cultivate, grow, and maintain core principles including, but not limited to, continuous improvement, self-organization, adaptive planning, and value driven development, using methodologies and frameworks such as LEAN, SCRUM and others.
Additionally, you will possess a growth-mindset, be team-oriented, have strong interpersonal skills, and possess the ability to deal with ambiguity; applicants must also demonstrate an aptitude for team communication and collaboration.
Key Responsibilities also include:
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
Qualification:
Bachelor degree in Computer Science, Information Technology, Healthcare Technology, Life Sciences, or related discipline. Knowledge of regulations and standards that affect the health care 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
The Company is committed to complying with the California Privacy Rights Act ("CPRA") effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
