Quality Assurance Engineer - Hybrid

Title: Quality Assurance Engineer - Hybrid

Mandatory skills:

Supplier quality,
Project management,
FDA regulations, FDA regulated environment,
lifecycle risk management standards, ISO 14971, formal quality systems, ISO 13485, ISO 9001,
manufacturing methodologies, quality methodologies, QFD, six-sigma, lean,
statistical analysis techniques, statistical analysis tools,
technical product documentation, diagrams, schematics, flow-charts,
Microsoft Office tools, Word, Excel, PowerPoint, Outlook,
PC tools, Windows OS, local, network based file systems,
production processes, product quality, product problems, production quality data,
CAPA activity, quality management system, nonconforming materials, manufacturing processes, part deviations

Description:

Self-sufficient go-getter with quality mindset. Associate will be working closely with the supplier quality team to address gaps within supplier quality and distribution systems. They will be expected to pull and review data and work with internal and external groups to implement solutions. Prior experience within manufacturing environment and data analytics is strongly desired. Ability to read and interpret blueprint requirements is a plus.

Position Summary:
The Quality Assurance Engineer provides technical support for various quality system processes to help ensure excellent product quality throughout product lifecycles.

Position Responsibilities:
Drive continuous improvement actions focused on product quality.
Works with Engineering and Manufacturing to develop acceptance criteria for production processes.
Works with Service and the Complaint Handling Unit to investigate product problems, perform root cause analysis and identify possible corrective actions.
Analyzes production quality data to identify trends or issues which require action or CAPA activity.
Assists in creating and implementing procedures in the quality management system.
Assists in the review and disposition of nonconforming materials.
Assists in the creation and validation of manufacturing processes.
Conducts internal audits of production processes and report results.
Reviews manufacturing process and part deviations.
Creates quality alerts when acceptance activities need to be adjusted.
Supports external regulator or customer audits
Provides response to inquiries related to quality assurance arising from tenders or other sales efforts.
Performs other duties as requested. Essential competencies:
Bachelor of Science degree in Engineering or related field.
3+ years relevant work experience.
Demonstrated ability to analyze, evaluate and control risk following lifecycle risk management standards (e.g. ISO 14971).
Experience with manufacturing / quality methodologies such as QFD, six-sigma, lean, etc.
Understanding of statistical analysis techniques and tools.
Experience with formal quality systems such as ISO 13485 or ISO 9001.
ASQ or related quality certification is preferred.
Work experience in a FDA regulated environment is preferred.
Proficiency in reading and understanding technical product documentation (diagrams, schematics, flow-charts, etc.)
Proficient in the use of Microsoft Office tools such as Word, Excel, PowerPoint, Outlook, etc.
Comfortable with using PC tools and Windows OS, with a working knowledge of local and network based file systems.
Excellent verbal and written communication skills using the English language.
Able to coordinate multiple activities and actions of persons contributing to assigned tasks.
Detail oriented with good organizational and record keeping skills.
Ability to work independently and as part of a team.
Proactive and timely in execution of assigned tasks.
Able to be flexible and adaptable when needs and priorities change

Physical demands and work environment:
Physical Demands - While performing the duties of this job the employee will be sitting for extended periods, will need to use a computer/mouse/keyboard/monitor and will communicate and listen both in-person and over the phone.
Work environment - The work environment is in an office setting with minimal noise level.

Top 3-5 Must Have Non-negotiable Skills Required:
Ability to work unsupervised, strong work ethic, self-starter
Experience working with data, comfortable with data analyst
Comfortable reading and understanding blueprints and other technical data
Strong interpersonal skills and attention to detail
Organized and be able to multi-task.

Nice to Have Skills:
Project management experience
Experience working with FDA regulations or other regulated fields
Supplier quality experience

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 :

VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008