Senior Design Quality Engineer

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Written by AI from the job title and company, not by Merit Medical Systems, Inc., so some details may not match this job. The employer's own page has the real description.

Overview

The Senior Design Quality Engineer at Merit Medical Systems, Inc. is responsible for ensuring that all design and development processes adhere to regulatory standards and quality requirements. This position involves collaborating closely with cross-functional teams to integrate quality assurance practices throughout the product lifecycle. The ideal candidate will drive continuous improvement initiatives and support the development of innovative medical devices that enhance patient care while demonstrating compliance with industry regulations and quality management standards.

Job Responsibilities

• Lead and facilitate Design Control activities in accordance with FDA regulations and ISO standards.
• Develop, review, and update design quality plans to ensure alignment with product development objectives.
• Conduct risk assessments and implement risk management strategies throughout the design process.
• Collaborate with cross-functional teams to evaluate and validate design outputs against design inputs.
• Participate in design reviews, ensuring appropriate documentation and adherence to quality standards.
• Drive the correction and prevention of non-conformances through thorough investigation and root cause analysis.
• Assist in the preparation and maintenance of documentation for regulatory submissions and quality audits.
• Provide training and mentorship to junior quality engineers and other team members on quality system processes.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, or a related field; Master’s degree preferred.
• Minimum of 5 years of experience in quality engineering within the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485, and other relevant standards.
• Proficient in Quality Management Systems (QMS) and risk management tools.
• Experience with design validation, verification, and statistical analysis methods.
• Excellent communication skills, with the ability to present complex information clearly and concisely.
• Detail-oriented with exceptional problem-solving abilities and a strong analytical mindset.

Technologies & Tools

The Senior Design Quality Engineer will utilize various technologies and tools, including statistical analysis software, document management systems, and design control software. Familiarity with computer-aided design (CAD) tools, risk management software, and project management applications is also essential for effectively managing quality-related tasks and ensuring compliance with industry regulations.

Ideal Candidates

Ideal candidates for the Senior Design Quality Engineer position are proactive and detail-oriented individuals who thrive in a collaborative environment. They possess a deep understanding of quality engineering principles and demonstrate a passion for improving product quality and safety. Strong interpersonal skills, along with the ability to influence cross-functional teams and navigate complex regulatory landscapes, will contribute to their success in this role. Additionally, a continuous improvement mindset and a commitment to excellence in medical device development are essential characteristics of a standout candidate.