Senior Quality Assurance Engineer

2 weeks ago

Coralville, Iowa, United States Integrated DNA Technologies Full time
Company Overview:
Integrated DNA Technologies (IDT) stands as a premier producer of custom oligonucleotides and innovative technologies tailored for genomics applications. Our endeavors are intricate and pioneering, attracting team members who are inquisitive and imaginative thinkers. We recognize that while science may be consistent, individuals are distinct.

Our Culture:
At IDT, we foster an environment where engaged individuals are inspired and have the chance to realize their full potential as part of a unified global team. IDT is one of ten Life Sciences companies under the Danaher umbrella, collectively propelling the discovery, development, and delivery of solutions that enhance and protect human health.

Position Overview:
This role is situated within the Regulatory Affairs and Compliance Department and offers a hybrid work model. As a key member of our global team, you will contribute to our mission by:

  • Leading root cause analyses associated with customer feedback and non-conformances (NCR), providing insights and recommendations to CAPA/SCAR teams.
  • Facilitating organizational quality goals, metrics, and reporting through the prompt review and investigation of CAPAs/SCARs, non-conformances, or process failures.
  • Engaging in targeted initiatives that may involve customer complaints, CAPA/SCAR, non-conformance, or process failure investigations, while spearheading problem-solving projects.
  • Representing Quality in cross-functional collaborations to devise, enhance, and sustain solutions addressing process failures, utilizing tools such as FMEA, risk assessments, and gap analyses.
  • Serving as a resource for colleagues in the application of investigative tools, including Ishikawa (Fishbone) Diagrams and 5-Why analysis, and providing guidance and training to cross-functional teams.

Essential Qualifications:
  • Bachelor's degree in Biology, Chemistry, Biomedical Science, or a related field.
  • A minimum of four years of experience in Quality Engineering within a regulated or standardized setting.
  • Proficiency in problem-solving methodologies and tools to facilitate investigations.
  • Experience in designing and executing experiments to support root cause analysis.

Preferred Qualifications:
  • Six Sigma Green Belt Certification.
  • Experience collaborating with cross-functional teams to identify root causes and appropriate solutions for complex issues.
  • Direct experience working with customers is highly advantageous.

Work Environment:
At IDT, we are committed to creating a more sustainable workforce. We acknowledge the advantages of flexible, hybrid work arrangements for eligible positions and are dedicated to providing fulfilling careers, regardless of the work setup. This position is eligible for a hybrid work arrangement, allowing for a combination of on-site and remote work.

Compensation and Benefits:
This role is also eligible for bonus or incentive pay. We offer a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and retirement benefits for eligible employees.

Equal Opportunity:
IDT and all Danaher companies are committed to equal opportunity, ensuring diversity and inclusion in our workforce and workplace.

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