Product Quality Engineer

Description

Position Summary:

This position provides expertise related to product quality including, but not limited to new product development, design transfer, sustaining engineering, manufacturing processes, change control in a manner that incorporates quality principles into the facility’s daily operations. 

Job Duties and Responsibilities:

• Promotes usage of and adherence to the requirements of NeoCoil’s quality management system.
• Participates in a variety of day-to-day product quality initiatives.
• Experience in the operation of quality control systems, application and analysis of testing and inspection procedures.
• Ensures usability, familiarity with quality costs, concepts and techniques, and auditing of quality systems for deficiency prevention, identification, and correction.
• Supports a variety of product risk management and risk mitigation measures from design concept through product obsolescence.
• Performs administration of supplier controls and monitors supplier performance.
• Ensures the correct implementation, integrity, and compliance of product Medical Device Files; reads/interprets electrical and mechanical specifications.
• Supports data gathering and data analysis for use in statistical analysis such as Gage R&R studies and process capability studies.
• Participates in assigned internal and external audit activities.
• Executes core duties and responsibilities of the role in accordance with the established skills competencies.
• All other duties, as assigned.

Requirements

Essential Skills and Experience:

• Proficient in all essential skills and experience required of the Quality Inspector role.
• Bachelor’s degree in engineering (Electrical or Mechanical) or related technical field or equivalent combination of training and experience.
• A minimum of 3-5 years of quality or regulatory experience is required. Experience in the medical device manufacturing industry is preferred.
• Proficient in understanding and interpretation of written and verbal instructions, directions, and technical information.
• Intermediate computer competency in MS Office (Outlook, Word, Excel, etc.) and business specific software (e.g. ERP, eQMS, CAD).
• Remains flexible and adaptable; willing and able to adjust to changing situations, priorities, or tasks. Stays positive and productive during change and works well in different environments or with different teams.
• Builds collaborative relationships; works well with others by building trust, communicating clearly, and supporting teamwork. Build strong working relationships across teams to achieve shared goals.

Reporting to this position: No direct reports.

Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.