Design Quality Engineer

Description

We are seeking a meticulous and experienced Design Quality Engineer to join our team. In this role, you will be responsible for ensuring that our product designs meet the highest quality standards and regulatory requirements. You will work closely with product development teams to integrate quality standards into all design and manufacturing processes. Key Responsibilities Quality Assurance Integration: Collaborate with product development teams to ensure quality standards are integrated into all design and manufacturing processes. Document Review and Approval: Review and approve design and development documents and plans to ensure conformance with quality system requirements. Risk Assessments: Conduct risk assessments and failure mode effects analysis (FMEA) for new and changed product designs. Quality Control Methods: Develop and implement quality control methods, procedures, and performance metrics for product design and manufacturing. Design Reviews: Participate in product design reviews to provide input on functional requirements, product designs, schedules, and potential problems. Problem Solving: Lead problem-solving and improvement activities to address quality issues and reduce product and process nonconformities. Process Audits: Conduct audits of design and manufacturing processes to ensure compliance with quality system requirements and identify opportunities for improvement. Training and Mentoring: Train and mentor staff on quality system requirements, quality tools, and best practices. Data Analysis: Compile and analyze statistical data to identify and prioritize areas for quality improvement. Reporting: Prepare and present reports on product and process quality to management and customers.

Skills

Quality assurance, Medical device, Quality engineering, remediation, risk management, Root cause analysis

Top Skills Details

Quality assurance,Medical device,Quality engineering

Additional Skills & Qualifications

Education: Bachelor’s degree in Engineering, Quality Assurance, or a related field. Experience: 1-3 years of experience in quality assurance or a related role. Skills: Thorough understanding of quality assurance methodologies. Familiarity with product design and manufacturing processes. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Proficiency in quality tools and statistical analysis. Ability to work collaboratively in a team environment.

Experience Level

Intermediate Level