Design Quality Engineer

Overview

Design Quality Engineer responsible for process validation, design control, and quality oversight across the product life cycle in a regulated medical technology environment.

What you'll do

• Implement comprehensive process validation plans and ensure smooth transition of new products to production, working under general supervision.
• Support the design control process, from validating design inputs to managing verification, validation, and design transfer.
• Ensure appropriate Quality Plans are made covering all stages of the product life cycle and support Quality Plan design.
• Validate key design inputs such as usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs.
• Provide effective oversight of the execution of the Quality Plan, Risk Management activities, and all design-related activities.
• Perform independent technical assessment of product quality performance and post-market product quality analysis.
• Lead quality-related problem-solving and root cause analysis during design and manufacturing.
• Use post-market analytics and statistics to report on product quality in the field, provide feedback to manufacturing, suppliers, or design teams, and initiate field actions when required.
• Act as single point of contact for the project team, ensuring hardware design meets quality and compliance standards at every milestone.
• Ensure product-development processes and documentation meet Quality System requirements in relevant regulations, e.g. CFR 820.30 and ISO 13485.
• Drive project decisions toward compliance, cross-functionally and globally.
• Ensure program documentation (Design History File) is created, controlled, and archived per the Quality System.
• Lead, prepare, and participate in or be the main escort for internal and external audits.
• Review and refine quality engineering documents, initiate quality improvement projects, and provide expertise in risk management.
• Frequently interact with supervisors and functional peer groups, including presentations of technical information on projects or schedules.

What you'll need

• Bachelor's degree (BE) in Engineering.
• Minimum 8 years of quality assurance experience.
• Strong design control and new product development experience.
• Strong analytical abilities.
• Professional knowledge of ISO 13485, FDA 820, ISO 14971, and FDA/MDR/MDSAP.
• Strong communication, problem-solving, and continuous improvement skills.
• Fluent in English, both written and spoken.
• Strong influence skills, presentation skills, and dispute-solving skills.

Nice to have

• Experience in the medical industry or a highly regulated industry.

Details

• Office-based role: in-person at least 3 days per week.