Quality Engineer II

Provide Quality Assurance technical expertise in support of manufacturing. Identify issues and analyze the cost of poor quality.

Support continuous improvement activities, including Process Failure Modes and Effects Analysis, kaizens, and lean manufacturing activities. Where appropriate, drive project completion in quality disciplines related to continuous improvement, problem solving (using formal methods such as DMAIC, 8D, etc.), and statistical data analysis.

Collaborate with Engineering to characterize manufacturing processes. Determine process capability, identify sources of variation in production processes, implement adequate control plans, and establish feedback mechanisms.

Support or lead projects of various scope and complexity.

Review, and analyze relevant data to identify opportunities for continuous improvement.

Conduct investigations of customer complaints to identify causes and appropriate actions to prevent recurrence.

Ensure thorough investigation and execution of corrective and preventive actions associated with internal process, vendor, and audit findings.

Support and define requirement for product line transfers and new process introductions.

Support the audit and qualification of new suppliers, and resolve supplier quality issues.

Support and/or perform internal audits of the Quality System, and support external audits of the Quality System.

Perform other related duties as assigned.

A Bachelor of Science degree in Engineering (Industrial, Manufacturing, or Mechanical), physical Science, or related field, from an accredited college or university

3+ years of experience as an engineer in a manufacturing environment

Understanding of Quality systems and practices in a manufacturing environment

Familiarity in Quality System Standards such as ISO 9001 and/or ISO 13485, AS9100

Excellent analytical and problem solving skills. Demonstrated ability in applying statistics to industrial practices

Experience working with customers and suppliers

Demonstrated project management

Able to work in a fast-paced, team-oriented work environment

Able to communicate complex technical information to all levels of the organization, able to write technical procedures and work instructions

Ability to read, write and speak English fluently

5+ years of experience working within a quality system

Experience in CNC machining, injection molding, and/or 3D printing environment(s) is preferred

Proficiency in using statistical analysis software (such as JMP or Minitab), and in applying statistics to industrial practices

ISO 9001 Audit Certification

Existing understanding of Quality systems and practices in a manufacturing environment

Demonstrated success in applying continuous improvement concepts, such as Lean and DMAIC

Excellent verbal communication and presentation skills