Design Quality Engineer - Quality Systems, IVD in Tucson, AZ at Apex Life Sciences

Date Posted: 9/15/2018

Job Snapshot

Job Description


Responsibilities:

  • 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.
  • 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
  • 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.


Qualifications:

  • BS in a directly related discipline required;  Advanced studies or training. 
  • 8 years of related experience in Engineering desired
  • Must have a medical device development understanding, partnered with Design Control regulations
  • 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.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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