Layer, Chiang, et al. Genome Biology
The Quality Engineer (Assay Development) will support quality engineering activities related to new product development of assays and reagents. Key responsibilities include design control, development and validation activities in accordance with FDA and ISO regulations. The ideal candidate will have a Quality Engineering background in a diagnostics, medical device or pharmaceutical company and possess a sound understanding of Quality Systems and processes.
- Support Quality Engineering activities related to new product development and introduction with a focus on design control, validation, risk management, continuous process improvement, and product life cycle compliance.
- As a project core team member, focus on product quality while managing technical and compliance risks.
- Work with all project Core Team Members to ensure that products meet customer, regulatory and business needs.
- Independently prepare project-specific Validation Master Plans, which includes process validation and test method validation.
- Support validation protocol execution and training, analyze test results and work with team to prepare final reports.
- Provide guidance for stability testing, test methods, sample plan definition, and validation development.
- Assist in setting specifications for raw-materials, in-process testing and final product release.
- Ensure required documentation is completed prior to project phase gates and product launch.
- Provide support for post-release design changes, including impact assessment of proposed changes to customer, product and business.
- Work with stake-holders for continuous improvement of the Quality Systems, including design control, document generation, and design testing processes.
- As appropriate, participate in internal and external audits.
- Bachelor's degree in Chemistry, Biology, Biochemistry or related field.
- Minimum of 5 years work experience in Quality Engineering with a focus on Assay Development with applicable knowledge of QSR, ISO and other applicable regulations.
- Sound knowledge of process and test method validation for reagent assay products.
- Excellent problem solving and analytical skills.
- Strong technical writing skills.
- Knowledge and experience of applied statistical tools for process capability, process control and design of experiments (experience with Minitab, SAS or related statistical software preferred).
- Effective interpersonal and communication skills.
- Capable of effectively handling multiple projects and prioritizing competing tasks while supporting team goals and timelines.
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