Job Description

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 Quality Assurance and Regulatory Affairs Department located in Boulder, CO and will be onsite. 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:

• Responsible for timely completion of review and/or investigation into Corrective Action Preventive Actions and other Quality Event Investigations (Nonconformances/OOS/OOT, Customer Complaints, Deviations).

• Provide cross functional support including gap analysis, FMEA, risk assessments, root cause analysis, tracking and trending, statistical modelling (linear regression, T-test, control charts, etc.).

• Responsible for implementing, maintaining, and improving IDT’s Quality Management System in accordance with ISO 13485, 21 CFR 820 and regulatory guidance documents.  Works closely with the IDT Global Quality Systems team. 

• Interact professionally and efficiently with manufacturing and support staff; administrate/coordinate the intra-department functionality of the eQMS with departments throughout the facility.

• Other duties as assigned.   

The essential requirements of the job include:

• Bachelor’s degree in scientific or technical discipline
• Minimum 3 years of experience working in a quality assurance role required.
• Minimum 3 years of experience working in medical devices or in vitro diagnostics required

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

• ISO 9001 and ISO 13485 internal auditor certification preferred
• Experience in validation such as process validation, IQ/OQ/PQ, risk management preferred.

The salary range OR the hourly range for this role is $90,000-$100,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) 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 .

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 applyassistance@danaher.com to request accommodation.

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