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Senior Quality Assurance Engineer
2 months ago
Company Overview: Integrated DNA Technologies (IDT) stands as a premier manufacturer of custom oligonucleotides and proprietary technologies tailored for genomics applications. Our operations are intricate and pioneering, attracting team members who are inquisitive and innovative thinkers. At IDT, we acknowledge that while science may be consistent, individuals are distinct. We foster a culture where engaged personnel are inspired and provided with opportunities to realize their full potential as part of a unified global team.
Position Overview: This role is situated within the Regulatory Affairs and Compliance Department and offers a hybrid work arrangement. At IDT, we are one cohesive team that values diversity, engages in constructive discussions, and promotes inclusivity. Together, we achieve remarkable outcomes.
Key Responsibilities:
- Lead root cause analyses concerning customer feedback and non-conformances (NCR), offering insights and recommendations to CAPA/SCAR teams.
- Facilitate organizational quality goals, metrics, and reporting through the prompt review and investigation of CAPAs/SCARs, non-conformances, or process failures as assigned.
- Contribute to organizational objectives by engaging in targeted initiatives, which may involve customer complaints, CAPA/SCAR, non-conformance, or process failure investigations, and spearheading problem-solving projects as needed.
- Oversee cross-functional collaborations as the Quality representative, developing, refining, and sustaining solutions to address process failures using various methodologies such as FMEA, risk assessments, and gap analyses to meet customer requirements, including those of high-value clients, while effectively communicating decisions and rationale to both internal and external stakeholders.
- Serve as a resource for colleagues in the application of investigative tools, such as Ishikawa (Fishbone) Diagrams and 5-Why analysis; may involve advising and assisting in training cross-functional teams and other Product Life-cycle team members on optimal problem-solving approaches within their areas of responsibility.
- Bachelor's degree in an engineering or scientific discipline.
- A minimum of 4 years of experience in Quality Engineering, with some exposure to regulated or standardized environments (e.g., ISO 9001).
- Expertise in problem-solving methodologies and the use of tools to drive investigations, such as Ishikawa (Fishbone) Diagrams and 5-Why analysis.
- Experience in designing and executing experiments to support root cause analysis.
- Six Sigma Green Belt Certification.
- Experience collaborating with cross-functional teams to identify root causes and implement appropriate mitigations for complex or non-routine issues, including risk identification and escalation.
- Direct experience working with customers is highly desirable.
Compensation and Benefits: This position is also eligible for bonus/incentive pay. We provide a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and retirement benefits for eligible employees.
At Danaher, we unite science, technology, and operational capabilities to enhance the real-world impact of future scientific advancements. We collaborate with clients globally to address their most intricate challenges, architecting solutions that harness the power of science. Our international teams are at the forefront of innovation across Life Sciences, Diagnostics, Biotechnology, and beyond. For further information, please visit our website.