Systems Engineer III - Hybrid

𝐓𝐢𝐭𝐥𝐞: Product Quality Engineer

𝐌𝐚𝐧𝐝𝐚𝐭𝐨𝐫𝐲 𝐬𝐤𝐢𝐥𝐥𝐬:

medical, pharmaceutical, automotive,

Office applications, customer service,

Marketing, Sales, Service, Operations, Medical Affairs, Quality Assurance, Regulatory Affairs,

product defects, subject matter experts,

JIRA, quality records, accountable, documentation, software backlog,

JIRA, issue investigation, defect analysis, issue triage, root cause analysis, risk assessment, risk documentation, requirements, software, testing, cross-functional coordination, project coordination

𝐃𝐞𝐬𝐜𝐫𝐢𝐩𝐭𝐢𝐨𝐧:

Position Summary:

Responsible for coordination and management of software backlog for one or more groups of related products (i.e. NovumIQ) to achieve defined program goals. This includes work related to the development of new products, and maintenance and engineering support of existing products. Interfaces with other departments including Systems, Marketing, Sales, Service, Operations, Medical Affairs, Quality Assurance and Regulatory Affairs to understand product requirements, communicate important information, and address issues relative to each product.

Position Responsibilities:

Drive and own investigations into observed product defects, coordinating with subject matter experts.

Determine the cause, impact, and severity of each issue, including affected users, interfacing systems, frequency, and affected versions.

Define the steps required to reproduce each issue, and identify the mitigations already in place.

Document the risk of leaving the issue unresolved, and route any gap in the risk management file to the risk owner.

Coordinate triage of new issue records so duplicates are closed with a written rationale and unique anomalies proceed to investigation.

Facilitate clear, concise, and accurate documentation of the investigation, analysis, and disposition of each issue.

Maintain issue records in JIRA as auditable quality records limited to facts and data, with each field complete or marked not applicable.

Hold cross functional peers accountable to deadlines and timelines to ensure projects are completed within the agreed upon timeline and budget.

Escalate distributed-product issues that violate a safety-critical requirement, risk control, or label claim for field-action review or nonconformance management.

Performs other duties as requested.

Essential competencies:

Bachelor's Degree in Engineering or related field and/or equivalent experience and 5+ years of experience.

Experience in a regulated industry highly preferred. (medical, pharmaceutical, automotive)

Must have strong organizational skills.

Must be fluent in English (both oral and written) with excellent oral and written communication skills.

Works independently, is self-motivated and able to complete tasks with minimal supervision.

Must have the ability to initiate and develop creative solutions.

Acts with a sense of urgency, illustrates ambition and drives for completion of tasks/projects.

Strong proficiency in Office applications skills.

Must be a team player, possess outstanding customer service skills and be self-motivated.

Possess good listening skills, and easily learn new skills and concepts.

Ability to manage time and prioritize work.

Must be flexible and adaptable.

Possess the ability to manage time and prioritize critical priorities.

Must demonstrate the ability to increase knowledge.

Key Skills:

Clear written and verbal communication.

Multi-disciplinary project experience across areas such as quality, risk, software, requirements and testing.

Strong critical thinking.

VIVA USA is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam-era, recently separated veteran, Active war time or campaign badge veteran, Armed forces service medal veteran, or disabled veteran. Please contact us at for any complaints, comments and suggestions.

𝐂𝐨𝐧𝐭𝐚𝐜𝐭 𝐃𝐞𝐭𝐚𝐢𝐥𝐬 :

Account co-ordinator: Sridharan Marimuthu

VIVA USA INC.

3601 Algonquin Road, Suite 425

Rolling Meadows, IL 60008