Senior Quality Assurance Technician - Pleasanton, CA

Calyxo, Inc. · Worldwide

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Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

Summary:

As a Senior Quality Assurance Technician, you will support the Design Quality Assurance team by ensuring medical devices, assemblies, and components meet engineering requirements. You will support product development activities by ensuring that finished devices are safe, reliable, and compliant to Calyxo quality and regulatory standards during the product development process.

In This Role, You Will:

  • Perform routine and first article inspections using various methods with calipers, micrometers, height gauges, optical comparators, vision systems, and other instruments

  • Develop CMM routines (MicroVu system or equivalent) based on engineering drawings, GD&T requirements and design specifications

  • Provide input and assist in the development of inspection procedures and test methods

  • Assist in conducting Gage R&R studies and validating test methods for continuous improvement of measurement systems

  • Support design verification/validation testing and other engineering test activities using various types of fixtures and test equipment and established procedures or protocols

  • Follow good documentation practices and maintain accurate records of inspections, test results, and nonconformities

  • Assist in training quality technicians or inspectors on methods for inspection or testing

  • Perform other Quality tasks as assigned

Who You Will Report To:

  • Director, Design Quality Assurance

Requirements:

  • Education: Competence in the areas above as demonstrated through education, prior experience, and training

  • Minimum 7 years experience, medical device preferred

  • Proficient using calipers, micrometers, height gauges, optical comparators, pin/ring gauges

  • Proficient using complex measurement and test equipment (CMM, tensile testing, etc.)

  • Ability to work inside a laboratory or controlled environment room

  • Ability to read and interpret engineering drawings with knowledge of basic GD&T principles

  • Excellent written and verbal communication skills

  • Analytical skills with experience in measurement data analysis, SPC, or Minitab

  • Proficient using MS Word and Excel

  • Must be able to lift 25 pounds, sit for up to 8 hours/day

  • Work location: On-site in Pleasanton

  • Travel: 10% travel

  • Full time employment

  • Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.

We also offer an attractive compensation package, which includes:

  • A competitive hourly rate range of $39.42 - $44.and variable in…

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