Quality Assurance Assistant

Job Type:

Full-time

Hourly

Monday through Friday

8am to 4:30pm

Benefits:

• Health Insurance


• Dental Insurance


• Life Insurance


• Voluntary Insurance


• 401(k)


• Paid time off
  


• Education Reimbursement

Responsibilities:

• Organization of Product Batch Files: Documentation, audit check & filing of records that describe the manufacturing of products, packaging items, and medical devices.


• Generation of Lot Code Labels: Printing and verification of labeling to assure accurate company, product, and batch identification specific to customer order and medical device requirements.


• Issuance of Manufacturing Build Packets: Compilation of build packets for orders to be manufactured including process work instructions, production aids, and special batch labeling.


• Maintenance of QMS Documents & Data: General verification, scanning, filing, and archive of Quality Records with data entry as required.


• Equipment Use: General equipment use will include PC terminal; printer/copier/scanner; Label printers; bar code scanner.


• Team Collaboration: Work closely with QC and Production concerning batch file reconciliation; confer with Customer Service & Shipping to ensure timely provision of paperwork & labels for product shipments.


• Assist with production, safety, and regulatory matters where support is needed for special inspections, auditing assignments, and committee projects.


• Perform other duties as assigned.
  

Qualifications/ Requirements:

• Good work ethic and positive attitude.


• Excellent organizational skills and attention to detail.


• Able to work independently or with a team.


• Knowledge of Microsoft Office Suite.


• Able to follow and understand quality management objectives and manufacturing procedures.


• Experience with ISO 13485, Quality Systems, and auditing preferred.


• Must be fluent in English for communication and reading safety instructions, procedures, and customer orders and parts.


• Ability to review and understand QMS procedures, protocols and instructions.


• Ability to read and interpret drawings and build sheets.


• Must be able to sit for long periods.


• Must be able to lift 25lbs regularly and occasionally lift up to 40lbs.

Janco, Inc. is an equal opportunity employer. Janco, Inc. does not discriminate in employment with regard to race, color, religion, national origin, citizenship status, ancestry, age, sex (including sexual harassment), sexual orientation, marital status, physical or mental disability, military status or unfavorable discharge from military service or any other characteristic protected by law.