Quality Engineer

Position : Quality Engineer

Location : Salt Lake City, UT

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Job Category: Engineering

Level of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

Hybrid schedule at least 3 days in office & 2 days remote

Job description:

Job 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 BD 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.

Minimum Qualifications:

This position requires:

· Bachelor’s degree in STEM (Science, Technology, Engineering, Math), and 2-5 years of engineering experience within the medical device or equivalent regulated industry OR,

· Master’s degree in STEM and one (1) 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.

Knowledge

· 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.

Skills

· 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.

Desired / Additional Skills & Knowledge

· 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).