Quality Engineer

SUMMARY:

The Quality Engineer position is responsible for coordinating NPI (New Product Introduction) projects and maintaining legacy products quality requirements. The Quality Engineer is responsible to ensure all quality actions required by the NPI project are planned, executed, approved, and closed. This may include but is not limited to: preliminary drawing reviews, control plan development, development of inspection criteria and inspection methods, determination of AQL levels and lead inspection reduction activities, assist in the design and procurement of gages and instruments, creation of the Device Master Record (DMR), and ensuring successful design transfer with the customer. When time allows and where required, this position assists with special projects, sustaining quality engineering, PFMEA maintenance, Customer Complaints, Internal Audits, External Audits, and other items assigned as by the Quality Manager.

ESSENTIAL JOB FUNCTIONS:

• NPI Coordination / Execution
• Coordinating and/or creating all documents required for a DMR – Control Plans, PFMEAs, Inspection Criteria, New Work Instructions, Process Specifications, Custom Gaging, Capability Studies, GR&R studies, Contact Material lists for specific products, or any other items required by the customer for the NPI launch
• Interact with Customer engineering and SQE/representatives – attendance at customer meetings
• Timely processing of Customer Complaints, Change Requests, NCMRs, Customer Returns, CAPA activities
• Internally communicate with Manufacturing Engineering, Purchasing, Planning/Scheduling, Quality Engineering, Senior Leadership Team, and other employees in a professional manner
• Perform work in accordance with ISO 13485, FDA, and other Medical Manufacturing Industry regulations and specifications both nationally and internationally

MARGINAL/LESS ESSENTIAL JOB FUNCTIONS:

When time allows and where required, this position assists with additional tasks that might be required from the Quality Manager or additional department managers and/or members of the Senior Leadership Team

EDUCATIONAL REQUIREMENTS:

• Must be a high school graduate or GED equivalent
• Minimum Associate Degree in Engineering or another related field preferred

TRAINING AND EXPERIENCE:

• 2-4 years of Quality Assurance experience
• 1-2 years of Quality Engineering for NPI is preferred
• Knowledge and experience in the development, implementation, and maintenance of an ISO 13485 compliant QMS preferred

Current Openings for Quality Engineer Jobs at XXX DO NOT USE XXX WishBone Medical, Inc

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