Quality Assurance Engineer

Quality Assurance Engineer I

Position Summary:

The Quality Assurance Engineer provides technical support for various quality system processes to help ensure excellent product quality throughout product life cycles.

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.