Senior Design Quality Engineer

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

Job Overview

The Senior Design Quality Engineer at Exact Sciences is responsible for ensuring the highest standards of quality and compliance in the development of innovative medical devices and diagnostics. This role entails collaborating with cross-functional teams to establish quality requirements and implementing best practices throughout the design and development process. The Senior Design Quality Engineer will actively contribute to risk management activities, design reviews, and validation efforts to facilitate the successful launch of products while adhering to regulatory standards and guidelines.

Job Responsibilities

• Develop and implement quality assurance strategies and processes for medical device and diagnostic products.
• Participate in design and development phases to ensure compliance with regulatory standards and internal quality requirements.
• Conduct design reviews, design verification, and validation activities, documenting findings and recommendations effectively.
• Facilitate risk management activities, including hazard analysis and failure modes and effects analysis (FMEA).
• Provide training and guidance to cross-functional teams on quality principles and practices.
• Collaborate with regulatory affairs to prepare and support submissions to regulatory bodies.
• Monitor and resolve quality issues as they arise during the development process.

Qualifications

• Bachelor's or Master’s degree in Engineering, Life Sciences, Quality Assurance, or a related field.
• Minimum of 5 years of experience in Quality Engineering, particularly in the medical device or diagnostics industry.
• Strong understanding of FDA regulations, ISO standards, and applicable quality regulations.
• Demonstrated experience with risk management methodologies and tools.
• Proficient in statistical analysis and quality control methodologies.
• Excellent written and verbal communication skills, capable of presenting findings clearly.
• Ability to work independently as well as part of a collaborative team environment.

Technologies & Tools

The Senior Design Quality Engineer will utilize various technologies and software tools in their daily tasks, including document management systems, statistical analysis tools (such as Minitab or JMP), and quality management systems (QMS). Familiarity with design software (like SolidWorks or AutoCAD) may also be beneficial to understand product designs thoroughly, while proficiency in Microsoft Office Suite is essential for documentation and communication purposes.

Ideal Candidates

Ideal candidates for the Senior Design Quality Engineer position possess a blend of technical expertise and strong interpersonal skills. They are detail-oriented individuals who can recognize potential quality issues and drive innovative solutions. An effective Senior Design Quality Engineer is expected to demonstrate leadership in promoting a culture of quality within the organization. Strong analytical skills, resilience in challenging situations, and the ability to adapt to fast-paced environments are essential traits that will contribute to their success in ensuring the highest quality of products.