Senior Quality Assurance Technician - Pleasanton, CA

About the role

The Senior Quality Assurance Technician position supports the Design Quality Assurance team at Calyxo, Inc., a medical device company focused on improving kidney stone treatment. The role involves routine and first-article inspections, developing CMM routines, assisting in the creation of inspection procedures, and supporting design verification/validation testing.

Responsibilities

• Support the Design Quality Assurance team by ensuring medical devices, assemblies, and components meet engineering requirements.
• Support product development activities by ensuring finished devices are safe, reliable, and compliant to Calyxo quality and regulatory standards.
• Develop CMM routines based on engineering drawings, GD&T requirements, and design specifications.
• Provide input and assist in the development of inspection procedures and test methods.
• Conduct Gage R&R studies and validate 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.
• Absorb and train quality technicians or inspectors on methods for inspection or testing.
• Perform other Quality tasks as assigned.

Requirements

• Minimum 7 years experience, preferably in medical devices.
• Competence in using calipers, micrometers, height gauges, optical comparators, pin/ring gauges, and complex measurement and test equipment (CMM, tensile testing, etc.).
• Ability to work inside a laboratory or controlled environment room.
• 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.
• Able to lift 25 pounds and sit for up to 8 hours/day.

Qualifications

• Education: Demonstrated competence in the areas above through education, prior experience, and training.

Skills

• Strong analytical and problem-solving skills.
• Experience with statistical process control (SPC).
• Knowledge of medical device regulations and quality standards.

Benefits

At Calyxo, you will enjoy an attractive compensation package including a competitive hourly rate range of $39.42 - $44, a variable incentive plan, stock options, and employee benefits such as a 401(k), healthcare insurance, and paid vacation. We also offer an opportunity to shape our company culture and contribute to a diverse and inclusive environment.

Pay

$39.42 - $44 per hour

Schedule

Full-time employment

What We Offer

• Participation in a knowledgeable, high-achieving, experienced, and fun team.
• Dynamic challenges to help you grow and be the best version of yourself.
• Opportunities to learn and contribute to shaping our company culture.
• Ownership and a stake in growing a mission-driven company through stock options.
• Employee benefits package including 401(k), healthcare insurance, and paid vacation.

Compliance

Calyxo is committed to fostering an environment where diversity and inclusion are valued. We seek to create a welcoming and diverse work environment with experienced, proven leaders and opportunities to impact people in significant ways. We are an equal opportunity employer seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Disclaimer

We prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

• Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. If you receive a request for information from any other domain, please contact us directly at info@calyxoinc.com to verify the legitimacy of the communication.