Job Description

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us, every moment of every day, to develop rapid groundbreaking solutions for the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics – from ideation and innovation through development and delivery of life-changing advancements in healthcare-associated infections, sexual health, critical infectious disease, virology and oncology applications. This important work takes more than just thinking, more than just leading, and more than simply doing – it takes all three. It takes people willing to bring their whole selves to work, operating with imagination, with initiative and achieving more than they ever thought possible.

POSITION SUMMARY:

Quality Technician I is the interface for assuring product quality during the manufacture of injection molded consumables in the use of Cepheid/Danaher Life Science Diagnostics finished goods with the support of Quality Engineering, Manufacturing Engineering, and Consumables Engineering. In this position, the Quality Tech supports the company’s’ efforts for confirming that the acceptance criteria and appropriate quality standards were sustained through the production cycle per the required product specifications. Quality Technician I support operations on the floor and is required to engage in Quality, Compliance, Safety and Continuous Improvement Initiatives.

Quality Tech I are responsible for the accuracy of measurements, reporting or escalating as applicable, documenting when appropriate, and adhering to pertinent regulations and policies.

This position utilizes a variety of manual, automatic, and semi-automatic machines in order to inspect and verify part conformity.

ESSENTIAL JOB RESPONSIBILITIES:

• Responsible for the production of injection-molded consumables within the Lodi facility-controlled environments.
• Adherence to applicable health, safety procedures and will be required to wear appropriate Personal Protective Equipment.
• Maintains cleanroom standards, practices, and housekeeping according to Standard Operating Procedures such as Daily PM, conveyor and runner clean up.
• Primary quality resource for all issues pertaining to the quality of the product from incoming inspection to the final inspection release of the consumable product.
• Conducts required testing, inspection, and review of procedures during the manufacturing process to ensure that products comply with quality standards.
• Sets up and performs destructive and nondestructive tests on materials, parts, or products to measure performance or adherence to conformity or applicable standards.
• Utilizing applicable diagnostic equipment or tests to collect, analyze, and record findings in order to determine conformity when appropriate, including failure investigation, consumable alert or advanced trouble shooting.
• Responsible for confirming Batch Records, Production logs completeness and compliance with QSR requirements.
• Responsible for the final release of production goods and to analyze, review accuracy of data in order to certify or reject material.
• Responsible for applying statistical quality control procedures where required.
• Escalate through the initiation of a Nonconformance Report (NCR) when nonconformity is found per applicable procedures within a timely and accurate manner.
• Provide communication or updates to management.
• Perform advanced visual inspection, dimensional measurement, and functional testing as required.
• Recommends modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability
• Performs advanced inspection with specialized equipment including the following Micro-Vu, Keyence Optical Measurement Systems, and product specific functional tests
• Audits documentation and production floor to verify conformity to quality and compliance standards
• Performs and participates in layered audits, internal audits, vendor audits as necessary
• Provides training related to the quality processes used in the manufacturing process
• Participate in continuous quality improvement projects and other related activities as assigned.
• Collaborates with cross-functional team to complete projects or tasks, including justifying immediate manufacturing matters or interests.
• Perform other duties as required or requested.

MINIMUM REQUIREMENTS:

EDUCATION OR EXPERIENCE (IN YEARS):

Minimum requirements by meeting one of the following:

High School diploma (or equivalent experience) with 1-2 years of related work experience, OR

AA or Technical Trade Degree with 0-1 years of work experience.

KNOWLEDGE AND SKILLS:

• Experience in compiling data to support metrics analyzing current process.
• Knowledgeable in Advanced Microsoft Office software.
• Ability to interface effectively with a cross-functional team environment.
• • Strong attention to details skills.

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

As part of the Danaher family of companies, our work at Cepheid is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

Company Description

Our molecular diagnostics products are increasing opportunities to improve patient survival and quality of life, by enabling medical providers to identify and treat diseases early. Passionate people who want to generate positive change in health care will find many opportunities here.