Sr Quality Engineer - Complaint and Process Failure Investigations

Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.

IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

This position is part of the Regulatory Affairs and Compliance Department located in Coralville, IA. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things.

In this role, you will have the opportunity to:

• drives root cause investigations related to customer complaints and non-conformances (NCR) and provides recommendations and feedback to CAPA/SCAR teams.
• supports organizational quality objectives, metrics and reporting through timely completion of review and/or investigation of CAPAs/SCARs, non-conformance, or process failure investigations, as assigned.
• supports organizational objectives by participating in targeted account initiatives; may include activities such as customer complaints, CAPA/SCAR, non-conformance, or process failure investigations and leading problem solving projects, as assigned.
• leads cross functional efforts, as the Quality representative, to develop, optimize and maintain solutions to address process failures through use of various tools such as FMEA, risk assessments, and/or gap analysis to meet customer, which may include high value customers, needs while effectively communicates decisions, or recommendations, and rationale utilized during investigations to determine root causes and mitigations to internal and external stakeholders.
• acts as resource for colleagues in explaining the use of various investigative tools, such as Ishikawa (Fishbone) Diagram, 5-Why or similar root cause analysis tools; may include advising and assisting in training cross functional teams and other Product Life-cycle team members on the best approaches to problems within the scope of their accountabilities.

The essential requirements of the job include:

• Bachelor’s degree in engineering or scientific field .
• minimum of 4 years of Quality Engineering work experience with some experience in a regulated or standardized environment (i.e. ISO 9001/ISO 13485).
• proficiency in problem solving methodology and utilizing tools to drive investigations such as Ishikawa (Fishbone) Diagram, 5-Why or similar root cause analysis experience.
• proficiency in the design and execution of experiments to assist in root cause.

It would be a plus if you also possess previous experience in:

• Six Sigma Green Belt Certification.
• working within cross functional teams to determine root cause and appropriate mitigations for complex/ non-routine issues, identify risks and escalate accordingly.
• working directly with customers highly preferred.

At IDT we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement.

This job is also eligible for bonus/incentive pay.

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and Retirement Benefits to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] to request accommodation.