Quality Technican I

Job Title:  Quality Technician I

Job Profile (Level-Job Family):  Quality and Regulatory Affairs > Quality Control – T1

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 2+ years of work experience in Manufacturing Quality, OR

  AA or Technical Trade Degree  in Business, Engineering, Medical or Technology field  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 in a fast-paced enivorment
• Ability to communicated via email and use radios
• Strong attention to details skills.
• Experienced in using hand tool or measuring tools
• Comfortable using and navigating on computer

  Physical requirements/abilities: 

Other:  Technical Qualification

• Capable of measurement conversion(s).
• Ability to interpret engineering drawings, schematic diagrams, formulas, and visual aids in the disposition of material conformity.
• Capable of consulting with management or engineering staff to determine and maintain quality and reliability standards.
• Detailed and quality oriented.
• Must be knowledgeable of definitions of critical, major, and minor characteristics.
• Understand the x, y, and z coordinate system.
• Demonstrates consistent quality, traceability, and controls standards.
• Capable of using inspection planning tools.
• Determine sample size for lots.
• Understand and demonstrate random sampling or testing methodology.
• Identify and report non-conforming material.
• Knowledge of Standard Operating Procedures (SOPs) and Quality assurance terminology.
• Use Ishikawa diagrams, 5 Whys, or other root cause analysis techniques.
• Creation of flow charts, check sheets, and control charts.
• Understand cost of quality and Plan-do-check-act quality cycle.
• Basic knowledge of Six Sigma or Continuous Improvement Lean.
• Statistical techniques, production processes, Acceptable Quality Level (AQL), trend charts.
• Plot data and recognize out-of-control conditions.
• Identify/recognize inspection errors and initiate resolution that includes documenting/recording.

  PREFERRED REQUIREMENTS:

• Injection molding.
• Understand basic processing and the relation to defects.
• Must have basic inspection techniques.

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. The “EEO is the Law” poster is available here.