Remote Incoming Quality Inspector - Medical Devices

Aspen Surgical; Douglas (AZ); On-site; USD 42,000 - 64,000; Full time

Job summary

Aspen Surgical in Douglas, AZ seeks a Quality Inspector to verify conformance of purchased products and prepare sterile loads for shipment. You will perform incoming inspections, document loads, and support QA initiatives to comply with FDA QSR and ISO 13485.

You should have a technical degree or high school diploma with at least one year in a regulated environment, strong English, and preferred Spanish. Ability to work independently and remotely is valued.

Qualifications

• Experience in a regulated industry such as medical devices preferred.
• Strong written and spoken English skills.
• Spanish proficiency preferred.
• Ability to work independently and remotely.
• Ability to read and analyze technical prints and drawings.
• Problem solving and corrective actions.
• Computer skills including MS Office and Minitab.

Responsibilities

• Perform incoming inspection activities at Douglas facility.
• Prepare documentation and confirm load assembly of product for shipment to external sterilizers.
• Perform First Article Inspections to qualify supplier's implementation of changed/new products.
• Support Quality Improvement initiatives to ensure products & processes comply with regulatory and Quality Management System requirements.
• Execute inspection plans for incoming purchased materials to ensure conformity to documented specifications.
• Verify receipt of Certificates of Conformity/Analysis as required and ensure such records are stored per procedures.
• Inspect product according to the requirements of a Skip-lot or Dock-to-stock inspection sampling plan to increase or decrease the level of inspections required based on risk, supplier performance and critical features.
• Maintain retained samples of finished products for key customers as required.
• Initiate non-conforming product dispositions for purchased materials.
• Support manufacturing and engineering to resolve technical issues.
• Execute quality release for shipments to final customers.
• Keep documentation complete, organized and properly identified.

Skills

Quality inspection

Documentation

Print reading

Root cause analysis

MS Office

Minitab

Bilingual English/Spanish

Education

Technical degree

High school diploma

Tools

Microsoft Office

Minitab

Job description

Aspen Surgical in Douglas, AZ seeks a Quality Inspector to verify conformance of purchased products and prepare sterile loads for shipment. You will perform incoming inspections, document loads, and support QA initiatives to comply with FDA QSR and ISO 13485.

You should have a technical degree or high school diploma with at least one year in a regulated environment, strong English, and preferred Spanish. Ability to work independently and remotely is valued.