Quality Engineer

Immediate need for a talented Quality Engineer. This is a 09+ Months Contract opportunity with long-term potential and is located in Salt Lake City, UT (Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID:25-83095

Pay Range: $63 - $68/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
 
Key Responsibilities:

• Leads or assists in the development of, and continuous improvement of, quality systems for R&D in compliance with 21 CFR 820, ISO 13485 and EN requirements with specific focus on design control.
• Ensures compliance with Client quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.
• Contributes as a team member on development projects carrying out assigned quality assurance responsibilities.
• Promotes advanced understanding of customer needs and processes to ensure relevant and innovative product development.
• Applies Design to Cost and Design for Manufacturability methods to support project leader in achievement of project objectives.
• Supports cross-functional planning, coordination, and reviews.
• Leads Risk Management plans/ reports and situational analyses for products under design authority.
• Promotes the use of statistics in the testing and control of quality.
• Applies Six Sigma methodology to support product development process.
• Actively mentors associate in related technical roles. Provide technical direction and frequent feedback. Participate and assist in their success.
• Contributes to assembly and maintenance the Design History File (DHF).
• Supports quality initiatives for plant issues.

Key Requirements and Technology Experience:

• Skills-5+ Yrs of experience in quality Engineering
• Medical Device is must have
• Risk Management
• Change control, qualification of supplier supplied components, design control, risk management, documentation process.
• Bachelor’s degree in STEM (Science, Technology, Engineering, Math), and 5 years of engineering experience within the medical device or equivalent regulated industry OR,  master’s degree in STEM and one (3) years of engineering experience within the medical device or equivalent regulated industry.
• The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.
• Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements.
• Good working knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, etc.).
• Complete understanding of quality assurance principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards.
• Advanced knowledge of Six Sigma methodology, statistical methods and analysis.
• Ability to translate customer needs into design inputs and specifications.
• Good knowledge and understanding of process development, total quality tools, and continual improvement approaches.
• Excellent technical writing skills.
• Strong critical thinking, analytical, and problem-solving skills.
• Ability to prioritize and multi-task many different forms of work input that are both strategic and operational in nature.
• Master’s degree in related engineering discipline.
• Excellent Project Management skills.
• Certified Quality Engineer (CQE) and/or Six Sigma Green/ Black Belt.
• Knowledge of engineering performance enhancement tools in the area of Design for Six Sigma (such as Voice of the Customer, Statistics, Design of Experiments, and Problem Solving).

 
Our client is a leading medical technology Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
 
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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