Senior Design Quality Engineer

A Senior Design Quality Engineer at Ultima Genomics plays a critical role in overseeing the quality assurance aspects of design and development. You will engage in establishing Design Control processes, managing risk assessments, collaborating with R&D teams, and ensuring compliance with ISO standards, particularly ISO 13485 and ISO 14971.

To qualify for the Senior Design Quality Engineer position at Ultima Genomics, candidates should have a Bachelor’s degree in Engineering with at least 7 years of relevant experience in the life sciences sector. Knowledge of ISO standards and experience in process validation are also highly valued.

The salary range for the Senior Design Quality Engineer at Ultima Genomics is between $115,000 and $130,000 when performed in California. Actual pay may vary based on skills, qualifications, and experience.

Ultima Genomics values professional development and provides opportunities for Senior Design Quality Engineers to grow through collaborative projects, continued education, and cross-functional team involvement. Mentorship and career growth pathways are encouraged within the company.

As a Senior Design Quality Engineer at Ultima Genomics, you will work on projects involving genomic technologies, focusing on ensuring compliance with design controls, participating in risk management activities, and collaborating on innovative product development initiatives.

A typical day for a Senior Design Quality Engineer at Ultima Genomics involves coordinating with R&D and engineering teams, conducting risk reviews, managing quality documentation, and participating in design review meetings to ensure product quality and compliance throughout the lifecycle.

The culture at Ultima Genomics is collaborative and focused on innovation. Senior Design Quality Engineers are encouraged to voice their insights, contribute to a supportive team environment, and engage in initiatives that further the mission of advancing genomics technology.

Describe specific experiences where you applied ISO 13485 and ISO 14971 requirements in past roles. Highlight how you ensured compliance during product development and the outcomes of any audits or assessments.

Discuss your methods for assessing project timelines and deliverables. Emphasize your tools for task management, such as project management software, and provide examples of how you've balanced competing priorities effectively.

Outline specific risk management strategies you have applied, such as Failure Mode and Effects Analysis (FMEA). Discuss how your approach minimized risks and led to successful project outcomes.

Share your strategies for facilitating effective communication, such as regular meetings, updates, and collaborative tools. Provide examples of situations where clear communication resolved potential design issues.

Discuss your involvement in verification and validation activities, emphasizing your approach to ensuring that design specifications and requirements are accurately tested and verified during development.

Explain your process for identifying, investigating, and resolving discrepancies. Emphasize the importance of thorough documentation and teamwork in addressing quality issues efficiently.

Highlight specific tools and software you've used for quality management, such as QMS software, data analysis tools, or statistical process control techniques, and explain how they improved quality assurance effectiveness.

Share your methods for staying informed about industry standards and regulations, such as attending workshops, subscribing to industry journals, or participating in professional organizations related to quality engineering.

Provide a specific situation where you faced a significant design challenge. Outline the steps you took to analyze and resolve the issue, focusing on your problem-solving abilities and teamwork.

Discuss your beliefs about the importance of robust Design Control systems in ensuring product quality. Highlight how your philosophy impacts your approach to quality engineering and your collaborative efforts with design teams.