Quality Engineer

Position Summary: 

The supplier Quality Engineer will be highly involved with the qualification, development and continued management of suppliers and contract manufacturing organizations (CMOs). This position will also be responsible for resolving and preventing issues with suppliers and CMOs and creating a strong positive lasting relationship with key partners. 

This position will report directly to the Director of Quality and will work under the guidance of the Manufacturing Development Director. 

Key Job Responsibilities:

• Report supplier performance metrics such as product quality and on time delivery to management
• Conduct routine audits and inspections of various sites located domestically and internationally
• Train suppliers as needed to internal inspection processes. 
• Manage external manufacturing processes to ensure compliance with customer and corporate requirements. 
• Data analysis and spotting trends. 
• Initiate CAPA and continuous process improvements.
• Maintain clear and concise records and reports. 
• Serve as supplier liaison 
• Recognize commonly used clamps, bottles, filters, and assembly methods.
• Understand and generate work instructions as needed related to inspection and assembly activities.
• Communicate current and new processes clearly
• Provide technical guidance to suppliers. 
• Investigate supplier related complaints
• Identify root cause and develop CAPA collaboratively with our supply base. 
• Craft customer facing complaint reports. 

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Education, Skills and Experience Requirements:

• Bachelor’s Degree in business or technical field.
• 4 years in similar role required.
• ASQ Certifications highly desired – CQA, CQE, CRE, or CSQP 

• Understand the nature of statistical sampling and sampling plans (esp. ANSI/ASQ Z1.4 and Z1.9)
• Well versed in QMS’ (especially ISO 9000 and/or 13485
• Working knowledge of auditing (system and process)
• Need to understand and demonstrate NAI assembly construction and processes.
• Willing to get hands on and work directly with suppliers and manufacturers. 

• Ability to work with constructive conflict
• Must possess strong analysis/critical thinking/problem-solving and communication skills
• Ability to communicate with a wide variety of individuals and across many cultures
• Proven engineering experience particularly with FMEA is a plus
• Knowledge of thermoplastic, silicone/LIMs, processing is a plus
• Knowledge of a second language is a plus (German, French, Chinese)
• Travel up to 50%, domestic and international.