Design Assurance Quality Engineer

Join a Leading Innovator in Medical Device Development as a Design Quality Assurance Engineer Are you ready to take your career to the next level in a dynamic, collaborative, and forward-thinking environment?

This is your opportunity to contribute to life-changing medical technologies while growing professionally in a supportive and inclusive workplace.

Why This Role is Right for You As aDesign Quality Assurance Engineer, you'll play a pivotal role in ensuring the safety, quality, and effectiveness of cutting-edge medical devices.

You'll be part of a team that values your input, encourages innovation, and supports your career development.

What Youll Do Lead quality engineering efforts on new product development projects, guiding teams in establishing robust quality documentation and processes.

Plan and execute pilot production and scale-up activities for new product introductions.

Apply quality systems, regulatory standards, and industry best practices throughout the product lifecycle.

Conduct design risk assessments to ensure products meet intended use and safety standards.

Manage CAPAs, change controls, audits, product releases, and design documentation.

Collaborate with customers and suppliers to maintain open, proactive communication and ensure quality expectations are met.

Resolve technical issues and contribute to continuous improvement initiatives.

Lead quality roles on client programs, supporting the design and implementation of new methodologies and technologies.

Maintain comprehensive documentation across all phases of research and development.

Coordinate with external partners to meet project timelines and deliverables.

What You Bring A Bachelors degree in Engineering or a related field.

At least 3 years of experience in medical device design, development, or quality assurance.

Strong communication skills and a customer-focused mindset.

Proven ability to lead product verification and validation activities.

Familiarity with FDA QSRs, ISO 13485, and medical device regulations.

Knowledge of statistics and probability.

Experience with manufacturing process development and electronic quality management systems (eQMS) is a plus.

Lean or Six Sigma certification and auditing experience are desirable.

A proactive, flexible, and resourceful approach with a drive to succeed.

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