Principal Quality Engineer, Supplier Qualification Program

1 month ago

Coralville, United States Integrated DNA Technologies Full time

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 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:Analyze and improve key supply chain KPIs related to supplier quality (e.g. Supplier OTD (past due)) through the development of long-term supplier relationships through various activities including participation in customer and registrar led audits, review of supplier audit reports and participation in technical meetings to monitor and assess supplier performance, improve supplier communication, discuss existing or potential problems, review deficiencies, review analytical data, review improvement opportunities, and educate suppliers on IDT quality requirements. This can include facilitating the technical meetings as appropriate.Ensure adherence to the supplier qualification and approval process including ensuring that the following are maintained: supplier certification statuses, the supplier risk register and,by working with Quality Assurance, audit schedules and lead supplier performance improvement projects to increase the supplier's capability of consistently meeting IDT requirements and generate cost reduction ideas.Work with Design Assurance and Purchasing Management to ensure that IDT requirements are appropriately established for each material and used as criteria in the supplier selection and qualification process.Work cross-functionally to initiate and complete internal/departmental quality documents and processes (e.g. NCMR, PCO), represent Quality in customer and registrar led audits, maintain and update the supplier risk register and audit schedule, in conjunction with Purchasing Management ensure supplier performance is regularly reported and appropriate and timely corrective actions are implemented as necessary.Act as resource for colleagues in explaining supplier quality concepts and requirements; may include advising technical teams, Purchasing Management, other QA personnel and Supplier Quality teammates on the best approaches to problems.The essential requirements of the job include:Bachelor's degree in science, medical, or technical field required.minimum of 7 years of experience in a quality assurance, manufacturing or technical role.minimum of 3 years of experience in a regulated or standardized environment (i.e. ISO 9001/ISO 13485).Previous experience with audits.highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat.It would be a plus if you also possess previous experience in: understanding FDA QSR/cGMP standards (highly preferred).following DBS, RoHS and REACH requirements.identifying, analyzing and mitigating risk associated with suppliers.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 position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for IDT can provide.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.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 applyassistance@danaher.com to request accommodation.

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