Quality Assurance Engineer- Level II

Responsibilities:

• 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.
• nalyzes production quality data to identify trends or issues which require action or CAPA activity.
• ssists in creating and implementing procedures in the quality management system.
• ssists 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.

Requirements:

• 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 and or CFR 210 & 211.
• SQ 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.
• bility to work independently and as part of a team. Proactive and timely in execution of assigned tasks.
• ble to be flexible and adaptable when needs and priorities change Physical demands and work environment: