Integrated DNA Technologies (IDT)
Sr. Manager Quality Systems, In Vitro Diagnostics
Integrated DNA Technologies (IDT), Boulder, Colorado, United States, 80301
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 group located in Boulder, CO, USA and will be hybrid. 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:
Provide leadership, direction, and hands-on involvement for quality management of IDT’s in vitro diagnostics portfolio.
Ensure compliance with applicable regulatory quality systems standards and regulations.
Lead a high performing team driving continuous improvement in conjunction with the global quality systems and regulatory affairs teams as well as other key stakeholders including operations.
Other duties as assigned.
The essential requirements of the job include:
Bachelor’s degree in scientific or technical discipline required.
Minimum of 7 years of experience in medical devices or in vitro diagnostics required.
Minimum 5 years managing a quality system in accordance with ISO 13485/MDSAP/21 CFR Part 820 required.
Previous experience managing direct reports in a Quality function required.
It would be a plus if you also possess previous experience in:
Excellent problem-solving abilities. Able to remove barriers and enable teams to meet objectives.
Proven ability to lead teams and peers through ambiguity, frequent change and effective decision making.
The salary range for this role is $117,000 to $150,000. 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.
We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
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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 group located in Boulder, CO, USA and will be hybrid. 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:
Provide leadership, direction, and hands-on involvement for quality management of IDT’s in vitro diagnostics portfolio.
Ensure compliance with applicable regulatory quality systems standards and regulations.
Lead a high performing team driving continuous improvement in conjunction with the global quality systems and regulatory affairs teams as well as other key stakeholders including operations.
Other duties as assigned.
The essential requirements of the job include:
Bachelor’s degree in scientific or technical discipline required.
Minimum of 7 years of experience in medical devices or in vitro diagnostics required.
Minimum 5 years managing a quality system in accordance with ISO 13485/MDSAP/21 CFR Part 820 required.
Previous experience managing direct reports in a Quality function required.
It would be a plus if you also possess previous experience in:
Excellent problem-solving abilities. Able to remove barriers and enable teams to meet objectives.
Proven ability to lead teams and peers through ambiguity, frequent change and effective decision making.
The salary range for this role is $117,000 to $150,000. 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.
We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
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