Senior Quality Engineer, Design Assurance and Risk Management

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Overview

The Senior Quality Engineer, Design Assurance and Risk Management at Integrated DNA Technologies will play a crucial role in ensuring that products meet the highest quality standards and regulatory requirements throughout the design and development process. This position focuses on identifying, assessing, and mitigating risks associated with product design, while also implementing quality assurance protocols to enhance product reliability and compliance. The ideal candidate will collaborate with cross-functional teams to facilitate process improvements, validate product quality, and support ongoing technical evaluations that align with industry best practices.

Job Responsibilities

• Lead quality assurance efforts throughout the product development lifecycle, ensuring adherence to design controls and risk management standards.
• Conduct design reviews and risk assessments, identifying potential issues and implementing strategies to address them effectively.
• Develop and maintain quality documentation, including risk management plans, design history files, and validation protocols.
• Collaborate with R&D, manufacturing, and regulatory teams to ensure quality compliance with applicable standards and guidelines.
• Perform audits on processes and products, analyzing data to drive continuous improvement initiatives.
• Provide training to staff on quality control measures and compliance policies to foster a culture of quality within the organization.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field; a Master's degree is preferred.
• Minimum of 5 years of experience in quality engineering, with a focus on design assurance and risk management in a regulated environment.
• Strong understanding of ISO 13485, FDA regulations, and other quality management systems.
• Proficiency in quality tools such as FMEA, CAPA, and statistical process control.
• Excellent analytical and problem-solving skills, with a keen attention to detail.
• Effective communication skills, both written and verbal, with the ability to collaborate across diverse teams.

Technologies & Tools

The Senior Quality Engineer will utilize a variety of technologies and tools, including statistical analysis software (e.g., Minitab), quality management systems (QMS), electronic document management systems (EDMS), and design control software. Familiarity with risk management tools, such as Failure Mode and Effects Analysis (FMEA), is also essential. The ability to leverage data analytics platforms to monitor product quality metrics and compliance will enhance effective decision-making in this role.

Ideal Candidates

Ideal candidates for the Senior Quality Engineer position will possess a strong commitment to quality and compliance, demonstrating proactive risk management skills. They will be detail-oriented, capable of managing multiple priorities under pressure while maintaining a strategic focus on quality initiatives. A collaborative mindset and the ability to influence cross-functional teams are crucial, as is the capacity to mentor junior engineering staff in quality assurance practices. Strong organizational skills and a continuous improvement ethos will set successful candidates apart in this mission-driven environment.