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Senior Quality Assurance Engineer, Supplier Evaluation Program
2 months ago
Integrated DNA Technologies (IDT) stands as a premier producer of tailored oligonucleotides and exclusive technologies for genomic applications. Our operations are intricate and pioneering, attracting team members who are inquisitive and innovative thinkers, recognizing that robust data informs intelligent decisions. At IDT, we appreciate that while science may be consistent, individuals are distinct. We foster an environment where engaged personnel are inspired and have avenues to realize their full potential as part of a unified global team.
IDT is one of ten Life Sciences entities under the umbrella of Danaher. Collectively, we expedite the discovery, development, and delivery of solutions that protect and enhance human health.
This role is situated within the Regulatory Affairs and Compliance Department and supports a hybrid work model. At IDT, we are a cohesive global team. We celebrate our diversity, engage in constructive discussions, and uphold inclusivity. Together, we achieve remarkable outcomes.
Key Responsibilities:
- Evaluate and enhance critical supply chain KPIs associated with supplier quality (e.g., Supplier On-Time Delivery) by cultivating long-term supplier partnerships through various initiatives, including participation in audits led by customers and registrars, reviewing supplier audit documentation, and engaging in technical discussions to monitor and evaluate supplier performance.
- Ensure compliance with the supplier qualification and approval process, maintaining essential records such as supplier certification statuses and the supplier risk register, while collaborating with Quality Assurance to oversee audit schedules and spearhead supplier performance enhancement projects.
- Collaborate with Design Assurance and Purchasing Management to ensure that IDT standards are properly defined for each material, serving as criteria in the supplier selection and qualification process.
- Work cross-functionally to initiate and finalize internal quality documents and processes, represent Quality in audits, and ensure that supplier performance is consistently reported with timely corrective actions taken as necessary.
- Serve as a resource for colleagues in clarifying supplier quality principles and requirements, potentially advising technical teams and Supplier Quality colleagues on optimal problem-solving approaches.
Essential Qualifications:
- Bachelor's degree in a scientific, medical, or technical discipline.
- A minimum of seven years of experience in quality assurance, manufacturing, or a technical capacity.
- A minimum of three years of experience in a regulated or standardized environment (e.g., ISO 9001).
- Prior experience with audits.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
Preferred Qualifications:
- Familiarity with FDA Quality System Regulations and Current Good Manufacturing Practices.
- Knowledge of compliance with DBS, RoHS, and REACH standards.
- Experience in identifying, analyzing, and mitigating supplier-related risks.
At IDT, we are committed to fostering a more sustainable workforce. We recognize the advantages of flexible, hybrid working arrangements for eligible positions and are dedicated to providing fulfilling careers, regardless of the work setup. This position supports a hybrid work model, allowing for a combination of on-site and remote work.
This role is also eligible for performance-based bonus compensation.
We provide a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and retirement benefits for eligible employees.
Danaher Corporation and all affiliated companies are dedicated to equal opportunity employment, valuing diversity and the unique perspectives that arise from our varied workforce. We ensure that individuals with disabilities receive reasonable accommodations to participate in the job application or interview process, perform essential job functions, and access benefits and privileges of employment.
