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.
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.
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

Job Type: Contract

Pay: $48.00 - $52.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Preferred)

Experience:

• FDA QSR, relevant ISO and EU guidelines: 5 years (Preferred)
• SO13495, CFR 820, 21 CFR Part 11: 5 years (Preferred)

Ability to Relocate:

• Lake Forest, IL: Relocate before starting work (Required)

Work Location: In person