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Job Code: #16387
Title: Senior Design Quality Engineer
Job Location: Tucson, Arizona

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Job Description:

Our client in Tucson, AZ is seeking a Senior Design Quality Engineer for a 1 year contract opportunity.  Please forward your resume to tucsonjobs@pdsinc.com for immediate consideration.  Thank you!  
 

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.

 

ESSENTIAL FUNCTIONS:

  • 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.

 

Skills:

Knowledge, Skills and Abilities:

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

 

Education:

Formal Training/Education:

BS in a directly related discipline. Advanced studies or training.

 

Experience:

Typically requires a minimum of 8 years of related experience.

 

Attachments:  
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Skills:

Required

  • MEDICAL DEVICES
  • RISK ASSESSMENTS
  • LIFE SCIENCES
  • SOFTWARE DEVELOPMENT LIFE CYCLE
  • DESIGN CONTROL

Additional

  • ENGINEER
  • FDA
  • QSR
  • QUALITY ENGINEER
  • ADME
  • ANTIBODY
  • DIAGNOSTIC ASSAYS
  • EXPERIMENTAL DESIGN
  • LIFE CYCLE
  • MENTORS
  • PRODUCT DEVELOPMENT
  • PROJECT PLANNING
  • QUALITY ASSURANCE
  • QUALITY CONTROL
  • SPC
  • STAINING
  • STATISTICAL PROCESS CONTROL
  • TRAINING
  • VITRO
Languages:
Minimum Degree Required: Bachelor's Degree
Also Preferred:
 
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Work Performed
Onsite:
 

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