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Danaher Corporation Quality Technician Lead in Lodi, California

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

This position is part of the Lodi in Process Quality and will be located in Lodi. The in-Process Quality Technician team 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 support operations on the floor and oversee quality decision making and is required to engage in Quality, Compliance, Safety and Continuous Improvement Initiatives.

In this role, you will have the opportunity to:

The essential requirements of the job include:

  • High School diploma (or equivalent experience) with 4-5 years of related work experience working in plastic injection molding and 2 + years in working in a Quality position.

OR

  • Bachelor’s degree in related field with 2 + years of experience

It would be a plus if you also possess previous experience in:

  • As a Quality Technician position with knowledge about QSR qualifications and validation of facility/utility and computer systems.

Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

JOB DESCRIPTION

Job Title: Quality Technician Lead

Job Profile (Level-Job Family): Quality and Regulatory Affairs > Quality Control – T3

POSITION SUMMARY:

Quality Technician Lead is part of 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 Lead 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 Lead support operations on the floor and oversee quality decision making and is required to engage in Quality, Compliance, Safety and Continuous Improvement Initiatives.

Quality Technician Lead is responsible for allocating resource and training for team members daily on the manufacturing floor. Quality Technician Lead are to act proactively to ensure smooth team operations, effective collaboration and oversee day-to-day operation. Lead by setting a good example and engage the team to achieve goals. Represent QT in proposal teams to ensure that flow down requirements and customer quality notes are understood and built into the proposal statement of work (SOP). Help define acceptance criteria and test protocols.

ESSENTIAL JOB RESPONSIBILITIES:

  • Interpret and provide guidance, coaching and mentoring to other functions and, where necessary

  • Define, develop, and implement quality assurance strategies and processes

  • Drive best practices for test, test execution, and test management

  • Implement inspection strategy. Maintain, expand, and improve our process

  • Work with customer success team to triage and identify bugs, collaborate with the development team to develop a comprehensive testing plan

  • Perform product releases

  • Stay up to date with new testing tools and test strategies and improve efficiency

  • Work with teams and stakeholders to deliver product initiatives

  • Responsible for providing quality assurance to support requirements gathering, testing, and configuration baseline management

  • Create an inspiring team environment with an open communication culture

  • Responsible for oversight of corrective action, preventative action, and continuous improvement activities throughout the organization.

  • Work with Engineering, Purchasing, Manufacturing, Suppliers, and Program Management to promote a cross functional approach to successful project execution.

  • Help project teams with the identification of risks and opportunities and the development and execution of risk mitigation plans and actions.

  • Work with cross functional teams to address corrective actions, preventative actions, and continuous improvement opportunities.

  • Develop improvement plans to reduce defects in various processes through data analysis and team problem solving.

  • Work closely with manufacturing engineering and project teams to develop tools, fixtures, and assembly and test procedures to support high quality manufacturing project and product deliverables.

  • Coordinate and manage NC rework task

  • Support on time delivery by reviewing and ensuring lots and pallets are ready to ship

  • Support sustainment activities by providing expertise in process testing and Counter-Measurement duties

  • Work with the Supervisor to capture requirements and document as well as maintaining a requirements traceability

  • Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP.

  • Practices and against established SOPs/standards.

  • Actively participates on project teams as assigned by supervisor.

  • Coordinates and leads projects within group without supervision.

  • Completes on the job training for each assigned job task.

  • Cross trains on other job tasks within department.

  • Assists with training other individuals within the department on specific tasks.

  • Performs training other individuals within department per assigned training plans.

  • Assists management with the development of training plans within department and trains others.

  • Develops training plans and trains others, including training outside of area of responsibility.

  • Sustain and ensure Compliance.

  • Attend daily management meeting.

  • Performs 2nd review/release approval of lots.

  • Initiates non-conformance reports for lots that do not meet requirements.

  • Routinely reviews specifications/ standards/ inspection plans for compliance to current regulatory requirements.

  • Initiates new specifications with supervisor input as needed for new materials.

  • Participate in audits as assigned by management.

  • Understand customer impact and functionally of products

  • Participate in cross function project

  • Discover training needs, documentation revision updates and provide coaching

  • Encourage creativity and risk-taking

  • Responsible to produce 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.

  • Quality resource for all issues pertaining to the quality of the product from incoming inspection to the final inspection release of the consumable product. Makes day-to-day decisions on product quality

  • 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.

  • Lead through DBS, use PSP for problem solving

  • 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.

  • Identify and support requalification activities with manufacturing engineering

  • 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.

  • support the tracking of deficiencies from initial identification through closure and maintain statistics on deficiencies by problem type, date, and priority

  • Perform other duties as required or requested.

MINIMUM REQUIREMENTS:

Education or Experience (in years):

Minimum requirements: In a Quality Technician III position with knowledge about QSR qualifications and validation of facility/utility and computer systems. Ability to work independently and as part of a team. Strong capability of using measurement tools such as; optical comparators, calipers, gauges, micrometers, Micro Vu/CMM machines, etc. with one of the following:

High School diploma (or equivalent experience) with 4-5 years of related work experience working in plastic injection molding and 4 + years in working in a Quality position.

OR

Bachelor’s degree in related field with 2 + years of experience

Knowledge and skills:

  • Experience in compiling data to support metrics analyzing current process.

  • Knowledgeable in Advanced Microsoft Office software. Excel, Minitab

  • Ability to interface effectively with a cross-functional team environment.

  • Strong attention to details skills.

  • Knowledge of quality control principles and practices

Physical requirements/abilities:

Posture and Movement equal to but not less than requirement of the following:

Position

1-2 hours

2-4 hours

4-6 hours

6-8 hours

Stand

Walk

Sit

Bend

Reach

Grasp

Push/Pull

Squat

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.

  • Basic calibration knowledge.

  • Measure using surface plate layouts.

  • Intermediate knowledge and experience with SAP/MES ERP.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid

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