Principal Quality Engineer
2 weeks ago
We are seeking a highly skilled Principal Quality Engineer to join our Regulatory Affairs and Compliance Department. As a key member of our team, you will be responsible for ensuring the quality and compliance of our medical devices.
Key Responsibilities:- Support all phases of product development, including software as a medical device, through design controls, risk management, usability, systems engineering, architecture, design verification and design validation.
- Ensure compliance of these activities with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans.
- Work closely with Regulatory Affairs in preparation of global regulatory submissions, including FDA pre-submissions, 510k, IVDR CE certifications technical files, etc.
- Facilitate and participate in product risk management process supporting documentation compliant with ISO 14971 such as hazard analysis, FMEAs, risk assessments, etc.
- Work independently and with project team members to develop and improve product and processes to reduce variability and increase robustness throughout the development cycle for multiple projects.
- Bachelor's degree in science, medical, or technical field required.
- Minimum of 7 years of experience supporting design controls related to development of regulated medical devices with integrated software or software as a medical device required.
- Strong working knowledge of ISO 13485, 21 CFR 820 and ISO 14971 required.
- Demonstrated understanding of technical/scientific principles that relate to multiple and diverse product lines or manufacturing processes.
- Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat.
- Software design and development process following 62304 guidance.
- Experimental design and assay development process.
- Identifying, analyzing and mitigating risk.
Danaher Corporation is a global leader in the life sciences and diagnostics industries. We are committed to equal opportunity and diversity in the workplace.
We offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance and Retirement Benefits to eligible employees.
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Principal Quality Assurance Engineer
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Coralville, Iowa, United States Integrated DNA Technologies Full timeJob SummaryIntegrated DNA Technologies (IDT) is a leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. We are seeking a highly skilled Principal Quality Engineer, Design Assurance and Risk Management to join our Regulatory Affairs and Compliance Department. This role will be based in Coralville, IA, and will...
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Principal Quality Assurance Specialist
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