Assembler III
Job Description
SUMMARY:
Assemblers are responsible for the assembly, testing, and inspection of product according to documented Manufacturing Process Instructions (MIs), including cleaning and setup of workstation with proper equipment and materials. These individuals record functions and activities performed on Lot History Records (LHRs) and other Quality Records, as appropriate. They comply with documented requirements including company policies and procedures, including quality, safety, and environmental policies.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following (other duties may be assigned as necessary):
Reviews LHR to ensure correct documentation is at workstation(s); obtains new documentation (i.e., latest MI revision) from supervisor or lead, if necessary.
Setup equipment, obtains tools and materials required by LHR.
Cleans workstations/equipment and performs line clearance per documented procedures.
Signs/dates documentation to verify completion of setup procedures.
Builds subassemblies and/or final assemblies per MIs.
Performs in-process inspections (i.e., qualitative [visual or tactile] and quantitative [dimensional]) of components/materials, subassemblies, and final assemblies to ensure that specifications are met and/or for data collection and analysis (e.g., statistical process control [SPC]).
Monitors equipment parameters and results of in-process inspection(s); as necessary, makes adjustments according to documented procedures to ensure product meets appropriate quality specifications.
Prepares labeling, audits labeled product for product information per LHRs (e.g., part number, description, expiration date), and assembles final product packaging. Records and dispositions labeling materials used, destroyed, and leftover from packaging operations.
Ensures that only products labeled correctly are released to finished goods according to documentation.
Prepares packaging for shipment by boxing, adheres inventory control labeling, and verifies that quantity of boxed product matches quantity recorded on LHR.
Assists lead assemblers in training new assemblers.
Records details of work and completes required portions of LHR to ensure traceability of each finished product lot. Assists supervisor and/or lead with inventory control issues (e.g., scrap transactions, back-flushing of finished products and subassemblies).
Records process and product measurement data for quality control purposes, as required.
QUALIFICATIONS:
A minimum of 5 years of manufacturing or related experience. Assembly and testing of medical devices, including soldering, gluing, and assembly using microscopes and electrical test measurement equipment.
Ability to read and understand written instructions.
EDUCATION and/or EXPERIENCE:
High school diploma or equivalent
Recommended Skills
- Auditing
- Data Collection
- Manufacturing
- Medical Material
- Packaging And Processing Duties
- Product Information Management