Quality Engineer

SUMMARY: The position of Quality Engineer is responsible for coordinating NPI (New Product Introduction) projects and maintaining legacy products quality requirements. The Quality Engineer is responsible for ensuring 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 DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)

• 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

QUALIFICATION REQUIREMENTS:

• Associate Degree in Engineering or other related field, preferred
• 2-4 years of Quality Assurance experience, required
• 1-2 years of Quality Engineering for NPI, preferred
• Knowledge and experience in the development, implementation, and maintenance of an ISO 13485 compliant QMS, preferred
• Experience with Document Control Software (Grand Avenue preferred)

MARGINAL JOB FUNCTIONS:

• Must be a team member and effectively communicate with others.
• Ability to manage projects through completion and meet deadlines.

PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk and hear. The employee is frequently required to stand; walk; and use hands to handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds.

WORK ENVIORNMENT: The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Associate will normally work in an office environment but may also be subject to high noise levels from machines and physical hazards from moving machine parts.

Current Openings for Quality Engineer Jobs at Red Star