Quality Engineer II

Redbock - an NES Fircroft company; California (MO); On-site; USD 70,000 - 100,000; Full time

Job summary

Redbock - an NES Fircroft company in the United States seeks a Quality Engineer II to lead investigations into return and non-return products, train technicians, and ensure compliance with SOPs. This role partners with Post Market, R&D, Design Assurance, Operations, and suppliers to drive root cause analysis and product improvements.

Call on experience with failure analysis of electro-mechanical devices and RF components, strong communication skills, and proficiency with MS Office; you will

Qualifications

• Bachelor’s degree in Electrical Engineering with 2+ years of relevant experience.
• Demonstrated problem-solving & failure analysis capabilities of electronics systems/components including those with RF communication
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Great written/verbal communication skills and ability to collaborate with other teams
• Ability to successfully multi-task and be adaptive

Responsibilities

• Understanding failure modes and approving product analysis for return and non-return complaints related to electro-mechanical devices performed by technicians
• Coordinating, training and supervising failure investigation activities for lab technicians
• Collaborating with other Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing, Supplier to help determine root cause of complaints
• Monitoring product performance and escalating any non-conformance issues with returned devices
• Creating, releasing new WI/SOPs in document control system
• Initiating and owning non-conformance investigations
• Training technicians to find root cause of complaints through sound failure analysis techniques

Skills

Problem solving

Failure analysis

Team collaboration

Communication

Education

Bachelor’s degree in Electrical Engineering

Tools

Microsoft Office

Job description

Quality Engineer II: (no third-party candidates will be accepted)

Responsible for creating test work instructions, training and mentoring technicians who work on investigation of return and not-return products. The QE will review result of investigations completed by others for accuracy, completeness and compliance to SOPs/WIs. The results of investigations can be used to escape product issues in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety. He/She will be responsible for creating monitoring IDs to assess the product performance and investigate performance changes using data analysis tools to find cause.

Responsibilities

• Understanding failure modes and approving product analysis for return and non-return complaints related to electro-mechanical devices performed by technicians


• Coordinating, training and supervising failure investigation activities for lab technicians


• Collaborating with other Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing, Supplier to help determine root cause of complaints


• Monitoring product performance and escalating any non-conformance issues with returned devices


• Creating, releasing new WI/SOPs in document control system


• Initiating and owning non-conformance investigations


• Training technicians to find root cause of complaints through sound failure analysis techniques

Qualifications

• Bachelor’s degree in Electrical Engineering with 2+ years of relevant experience


• Demonstrated problem-solving & failure analysis capabilities of electronics systems/components including those with RF communication


• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook


• Great written/verbal communication skills and ability to collaborate with other teams


• Ability to successfully multi-task and be adaptive

Preferred Skills

• Experience in Medical Device industry


• Familiarity with Post Market requirements and systems