Senior Design Quality Engineer

  • Responsible for establishing and maintaining Design Quality Assurance systems and processes. Ensures conformance and compliance to domestic and international quality and regulatory standards.

  • Defines Quality and Regulatory strategies for complex diagnostic assays in development and provides guidance to product development teams.

    • Demonstrates success in technical proficiency, creativity, collaboration with others and independent thought.

    • Expert knowledge of applicable regulations and standards, including FDA QSR Part 820, ISO13485

    • Expert knowledge of Quality engineering principles and concepts.

    • Experience in medical device, including software, reagents, and assay development, design control process.

    • Need medical device development understanding, partnered with Design Control regulations

  • Supports the Primary Staining Reagent, antibody, immunohistochemistry, detection reagent, and molecular probes, or CDx Design Quality teams that supports the delivery of portfolio projects for all life cycle teams.

  • Supports the development of primary staining reagents, immunohistochemical and in situ hybridization In vitro diagnostic (IVD) products, etc.

  • Maintains extensive knowledge of principles, theories, and practices in Design for Excellence activities such as Design for Manufacturability for complex diagnostic systems to include assays and reagents.

  • Provides strong understanding of molecular/cell biology techniques, relevant systems and reagent experience to staff.

  • Provides technical knowledge of Design and engineering principles and their application to ensure that cost-effective, reliable and high-quality systems that satisfy customer needs and business requirements are delivered.


  • Practices and mentors in the use of company concepts, policies and procedures, familiar with and follows standard practices.

  • Applies functional expertise routinely on the job.

  • Receives general direction and exercises considerable discretion as to work details.

  • Contributes to the definition and timely achievement of overall project goals.

  • Participates in efforts to define new components, products or processes.

  • Identifies and implements improvements to work processes.

  • Designs, plans and executes project related tasks.

  • Consults and provides training for areas of statistical quality control such as SPC, Process capability, DOE, etc.

  • Assures experimental quality through sound, independent, experimental design.

  • Participates on cross functional technical teams.

  • Provides technical direction and feedback to others.

  • Participates in project planning, process updates and contributes to experimental design.

  • Monitors work to ensure quality, and continuously promote Quality First Time.

Company Description:

About Ascent:

Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent's fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.

If you are ready to propel your career to new heights†read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

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