Quality Assurance Engineer – Manufacturing

Position Summary:

4 months contract ; May extend

Onsite

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.

� 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.

� 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.

� 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.

� 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.