Location: Aibonito, PR Pay Rate: $11.25 p/h Shift E: Saturday and Sunday 12-hour night shift 5:45pm-5:45am, and 2 days of Shift C
Summary: Responsible for performing both manufacturing and in-process quality (TIQ) activities within the Microbore, Heat Seal, and RAB departments. This position is cross-functional and will rotate between Manufacturing Operator and Assembler III-TIQ responsibilities based on production and business needs. The incumbent assembles, inspects, samples, audits, documents, and packages products in accordance with Bills of Material (BOMs), Specifications, SOPs, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Quality, Safety, and Environmental requirements
Essential Duties and Responsibilities:
Assemble components manually or through semi-automated processes following approved methods and specifications.
Verify materials and components are correct and in acceptable condition before use.
Perform visual inspection of products throughout all stages of manufacturing.
Conduct leak and blockage testing when required.
Package, palletize, and prepare finished products according to BOMs, specifications, and SOPs.
Maintain work areas in accordance with 6S requirements.
Document manufacturing activities accurately and completely.
Report equipment issues, unsafe conditions, and process abnormalities.
Support production line operations and material flow activities.
Quality (TIQ) Functions
Perform machine start-up verification activities according to specifications, procedures, and blueprints.
Complete required checker charts and quality documentation.
Conduct sampling and inspections according to applicable procedures and specifications.
Verify machine parameters, production counts, and batch completeness.
Perform line clearance activities, packing pre-run inspections, code changes, and label verification.
Conduct audits of packaging, palletization, and manufacturing processes.
Perform product inspections according to BOM, specifications, and SOP requirements.
Conduct quality testing including seal strength, blister thickness, and other required product evaluations.
Maintain SPC charts and document results manually or electronically.
Support protocol executions, validations, and process studies.
Review and verify material, solvent, and production documentation.
Transfer all required quality records and documentation for review at the end of the shift.
Education and Experience
High School Diploma or equivalent.
Manufacturing experience preferred.
Quality inspection experience preferred.
Prior experience in medical device manufacturing environments is highly desirable.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is $11.25/hr.
