Quality Engineer

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

• 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.

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).