Employment Type : Full-Time
With the support of Supervisors, Trainers, Quality Techs, and Engineering, a Manufacturing Associate II is essential to the manufacture of injection molded consumables for the use of Cepheid/Danaher Life Science Diagnostics finished goods. Associate II will be expected to provide guidance for Associate I while ensuring the successful completion and compliance in the initiation, maintenance, operation, packaging, inspection, environmental maintenance, and environmental control through injection molding. Manufacturing Associate II are the foundation to the Quality and Safety culture within the site and will be responsible to report as applicable, document when appropriate, and adhere to pertinent regulations and policies.
ESSENTIAL JOB RESPONSIBILITIES:
Responsible for the production of injection molded consumables within the Lodi facility controlled environments
Adherence to applicable health and safety procedures and will be required to wear appropriate Personal Protective Equipment
Recognizes when minor issues and defects and utilizes the processes in place to resolve the occurrence
Applies reasonable logical and rational reasoning to control contingency, gaps, or nonconformance in the process
Completes necessary documentation and/or escalates accordingly
Collaborates with cross functional teams on special projects and troubleshoots problems
Reports production units, job numbers, and labor hours
Monitors machine problems and informs the Supervisors and Leads of any issues
Responsible for following documentation compliance
Operates Manufacturing Equipment for Basic Start and restart functions of the robot, press trouble shooting, conveyor feeding trouble shooting, and basic injection alarm resolution
Responsible for auxiliary production devices to support production including scanners, pads, and removable equipment
Maintains cleanroom standards, practices, work equipment and housekeeping according to Standard Operating Procedures
Coordinates and confirms rework for a tote, bin, or lot
Applies basic lean principals for First in and First Out (FIFO), Kaizen, 5S, and Standard Work
Adherence of regulations and procedures pertaining to the manufacture of medical devices including basic Quality Assurance, Good Manufacturing Practices, Standard Work Instructions, 21 CFR Part 820
Understands QMS requirements for traceability
Responsible for traceability during the production of the lot
Documents inspections, operations, rework, or tests performed consistently and in real time
Responsible for quality, accuracy, and timeliness of information, data, and communication within the Device History Record or Electronic Batch Record production log
Executes line clearance during cavity changes
Provides training to other associates as needed
TRAINING RESPONSIBILITIES: (REQUIRED)
Complete all assigned and required training satisfactorily and on time
For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.
MINIMUM REQUIREMENTS:Education or Experience (in years):
High school degree (or equivalent experience) with 1-2 years of relevant work experience
Knowledge and Skills:
Ability to comprehend verbal and written English to interpret documents such as safety rules, operating instruction, and procedure
Basic knowledge of Microsoft software (Word, PowerPoint, Excel, Outlook)
Ability to cooperate with co-workers in areas of safety, quality, production, maintenance, and engineering
Exhibits the ability to work calmly and accurately under varied conditions
Basic Knowledge of Quality Systems
Good Documentation Practices
Right First Time average greater than 99% effectively
Technical Knowledge and Skills:
Mechanical, Safety, Compliance, and Quality aptitude
Problem Solving, Quality Data, and Mathematics
General computation including addition, subtraction, multiplication, and division of all units of measure including whole numbers, common fractions, metric measurement, and decimals
Capable of using data to make determinations to resolve production related issues
Inspection and Inspection equipment
Ability to handle, interpret, and troubleshoot basic measuring devices such as a standard tape measurement, a micrometer, Caliper, pin gauges, drop gages, and height gages
Understands gage repeatability, gage resolution, and techniques for measurement
Recognizes and interprets measurements that are outside a specified range
Understands specifications, tolerance
Basic understanding of part drawings
Capability to understand the part control plan
Aptitude for interpreting the lot and tote acceptance criteria
Physical requirements/abilities required:
Ability to work in a clean room environment
Ability to visually determine minute geometrical quality characteristics
Skilled hand-eye coordination for handling critical parts
Must have appropriate vision to perform detailed quality inspection as outlined in the SOPs, WIs, control plans, visual aids, and product drawings
Ability to stand at workstation for extended periods of time (8 hours or more) operating equipment and packaging products while closely monitoring and visually inspecting products and process
Ability to lift or carry 25 lbs. totes
Moves freely around machine to assure all working mechanisms are operating properly
Able to reach parts in machine and make adjustments, set-ups, change overs, inspections, feeding and securing parts
Posture and Movement equal to but not less than requirement of the following:
1-2 hours
2-4 hours
4-6 hours
6-8 hours
Stand
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Walk
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Sit
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Bend
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Reach
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Grasp
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Push/Pull
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Squat
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PREFERRED REQUIREMENTS:
Minimum two years in Manufacturing Environment
Experience working in a clean room environment
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.