03 Sep
Quality Control Supervisor (Medical Device)
Texas, Austin , 73301 Austin USA

Vacancy expired!

Cutting edge disposable PCR device company seeks exceptional QC Engineer SupervisorThis Jobot Job is hosted by: Hunter PraterAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $60,000 - $70,000 per year

A bit about us:Our client is developing a novel disposable molecular diagnostic device platform that will revolutionize the range of clinical diagnostics.

Why join us?Exciting startup cultureOpportunity for significant growthMedical, Dental & Vision InsurancePaid Time Off

Job DetailsOur client is seeking a Quality Control Engineer who will be integral to the development, commercialization, and maintenance of next-generation molecular diagnostic devices. Reporting to the QA Manager, this individual will lead the Quality Department's Test Team, guiding daily operations and providing supervision to the test technicians. The QC Engineer will help develop and deploy and continuously improve Test Team methods and SOPs to support product development and manufacturing under QSR medical device design controls. The QC Engineer will ensure that the Test Team can support product design change control as well as manufacturing process control. The successful candidate will have:
  • At least 4 years of increasingly responsible experience working as a QC Engineer in medical device or biotech product development and manufacturing (IVD experience a plus)
  • Have working knowledge of regulated quality, 21 CFR 820 and ISO 13485, design controls, inspection methods, good working knowledge of statistical methods, design verification and validation, and process validation and control
  • Experience leading a small team of technicians; able to work in fastpaced projects in controlled environments (e.g., laboratory or manufacturing settings).
  • B.Sc. in Engineering or Science related field or equivalent applicable experience
  • Ability to lead projects and participate as a testing and quality subject matter expert in team environments
  • Excellent written and verbal communication skills - able to train others in quality principles and operations
  • Applicable knowledge of Microsoft Office (including Excel) along with general computer experience in order to use and expand corporate data/document/project systems and install, operate, and monitor test equipment
  • Ability to read and interpret mechanical drawings (GD&T), electrical schematics (ANSI), and software specifications/flow charts (ISO)
  • Ability to sit, stand, walk, bend, and lift up to 25 lbs.
Skills and Responsibilities:
  • Create and deploy technically and statistically sound testing SOPs that adhere to quality guidelines
  • Be capable of creating/updating procedures to align with regulatory compliance and standards
  • Mechanically inclined and experienced in working with other engineers to design and construct test setups and create documented instructions and procedures
  • Lead efforts to define requirements and guide enhancements to quality management system IT infrastructure for more efficient test execution and collaboration
  • Drive continuous improvement of testing throughout the development cycle with testing methodologies that better extract information for assessment of non-conformances and support cross-functional root cause analysis
  • Be able to perform SPC, design verifications, product and manufacturing validations, and risk analysis; advise on testing statistics
  • Working knowledge of a wide variety of measurement and test equipment, including hand tools/instruments; able to research and specific additional testing systems
  • Ability to meet deadlines under pressure; able to occasionally work extended or non-standard scheduled to meet specific personal training, department, and production needs
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

Vacancy expired!

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