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Senior Quality Assurance Engineer
2 months ago
Company Overview: Integrated DNA Technologies (IDT) stands as a premier producer 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, recognizing that quality data fuels informed decisions. At IDT, we appreciate the uniqueness of individuals, fostering a culture where engaged personnel are inspired and have avenues 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 embrace our diversity, engage in constructive discussions, and uphold inclusivity. Together, we achieve remarkable outcomes.
Key Responsibilities:
- Lead investigations into root causes related to customer feedback and non-conformances (NCR), providing insights and recommendations to CAPA/SCAR teams.
- Contribute to organizational quality goals, metrics, and reporting through the timely review and investigation of CAPAs/SCARs, non-conformances, or process failures as assigned.
- Engage in organizational initiatives by participating in targeted account activities, including customer complaints, CAPA/SCAR, non-conformance, or process failure investigations, and spearheading problem-solving projects as required.
- Facilitate cross-functional collaboration as the Quality representative to devise, enhance, and sustain solutions addressing process failures, utilizing various tools such as FMEA, risk assessments, and gap analysis to meet customer needs, particularly for 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) Diagram, 5-Why, or similar root cause analysis methodologies; may include 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, preferably in a regulated or standardized environment (e.g., ISO 9001).
- Expertise in problem-solving methodologies and the application of tools to drive investigations, such as Ishikawa (Fishbone) Diagram, 5-Why, or similar root cause analysis techniques.
- 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, while recognizing risks and escalating as necessary.
- 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 expedite the real-world impact of tomorrow's innovations. We collaborate with clients globally to tackle their most intricate challenges, crafting solutions that harness the power of science. Our international teams are at the forefront of advancements across Life Sciences, Diagnostics, Biotechnology, and beyond. For more information, please visit our website.
Danaher Corporation and all Danaher Companies are committed to equal opportunity, valuing diversity and the unique perspectives contributed by our associates, customers, and shareholders.
