Quality Technician

Position Summary

Roembke Turnkey Solutions (RTS) is seeking a Quality Technician to support quality assurance, inspection, and documentation activities for the manufacturing of liquid silicone molded components used in medical device and industrial applications.

RTS is a small, ISO 13485 and ISO 9001 certified manufacturer where quality personnel work closely with production operators, mold technicians, and management to ensure product quality, traceability, and regulatory compliance.

Reporting to the Quality Manager, the Quality Technician is a mid-level position that plays a critical role in inspection, documentation, and quality system support, helping ensure products meet customer specifications, regulatory requirements, and internal quality standards.

Key Responsibilities

Inspection and Product Acceptance

·        Perform dimensional inspection using calipers, micrometers, optical comparator, height gauges, pin gauges, and vision systems.

·        Experience with automated or digital vision systems preferred.

·        Verify parts meet drawing specifications and acceptance criteria.

·        Record inspection data in the RTS PQD (Production Quality Documentation) system.

Production Quality Support

·        Support First Part Approval (FPA) and in-process inspection activities.

·        Assist with final acceptance inspection of production lots.

·        Ensure inspection documentation is accurate and complete.

·        Support in-process inspection activities using established sampling plans and inspection.

Device History Records (DHR)

·        Assist with compilation and verification of production documentation.

·        Verify job travelers, inspection reports, material certifications, and lot release documentation.

·        Ensure Device History Records are properly archived according to RTS record control procedures.

·        Verify production documentation to ensure full product traceability and compliance with RTS quality procedures.

Nonconforming Product and Corrective Action

·        Assist in documenting Nonconforming Product Reports (NCRs).

·        Support root cause investigations.

·        Participate in corrective and preventive action (CAPA) activities.

·        Assist with containment, documentation, and investigation of nonconforming products.

Process Monitoring and Documentation

·        Verify production documentation is completed according to Good Documentation Practices.

·        Review inspection records and production documentation for completeness.

·        Support environmental and cleaning documentation where applicable.

·        Ensure documentation follows Good Documentation Practices (GDP).

Quality System Support

·        Assist with internal & external audits and audit preparation.

·        Support maintenance of controlled quality documents and records.

·        Assist with updating procedures, work instructions, and inspection criteria.

·        Support calibration activities by verifying that inspection equipment

Required Skills and Qualifications

·        Associate degree or technical training in Quality, Manufacturing, Engineering Technology, or related field (or equivalent experience).

·        Ability to read and interpret engineering drawings and tolerances.

·        Experience with precision measuring instruments.

·        Basic computer skills and familiarity with digital record systems.

·        Attention to detail

·        Communication skills

·        Documentation discipline

Preferred Qualifications

·        Experience working in a manufacturing quality environment.

·        Experience with ISO 9001 or ISO 13485.

·        Experience with liquid silicone rubber (LSR), injection molding, or elastomer manufacturing

·        Familiarity with statistical process control or sampling plans.

Physical requirements

·        Ability to stand or walk for extended periods on the production floor

·        Ability to lift up to 25 pounds occasionally

·        Ability to handle small precision components and perform detailed visual inspections

·        Frequent use of hands and fingers for measuring instruments and documentation

·        Ability to work in manufacturing and cleanroom environments