Design Quality Assurance Engineer Role
We are seeking a skilled Design Quality Assurance Engineer to lead quality engineering efforts on new product development projects, ensuring the safety, quality, and effectiveness of cutting-edge medical devices. As a key member of our team, you will play a pivotal role in establishing robust quality documentation and processes.
About this Opportunity
This is an exceptional opportunity to contribute to life-changing medical technologies while growing professionally in a supportive and inclusive environment. You will be part of a dynamic, collaborative, and forward-thinking team that values your input, encourages innovation, and supports your career development.
Key Responsibilities
* 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.
Requirements
To succeed in this role, you will need:
* 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.
Becoming Part of Our Team
We offer a dynamic, collaborative, and forward-thinking work environment that encourages innovation and growth. If you are a proactive, flexible, and resourceful individual with a drive to succeed, we would love to hear from you.