Production Staff

**Summary**:
Nipro Canada Corporation is a manufacturer and distributor of disposable medical devices located in Lindsay, Ontario. We are committed to delivering innovative, high
- quality solutions in the form of renal, medical-surgical, and vascular products. This fundamental objective drives us to develop cutting-edge, value-added products, improving patient care and quality of life.

**About the Role**:
As Cannula Lab Assembler, the individual is responsible for assembling and packaging medical devices while maintaining the cleanliness of Cannula lab facility. This person requires tolerance of repetitive motion and aptitude for high precision work. Nipro Canada Corporation and its proximity are strictly smoking and vaping free. A fragrance-free policy is in force.

**Essential Functions**:
**Take individual responsibility for the integrity of their assemblies**
- Be familiar with Nipro Quality Policy
- Understand the purpose of the Nipro Quality System and how it impacts on their duties and responsibilities
- Be familiar with SOPs and work instruction pertinent to their functions

**Identify nonconforming materials**
- Be able to recognize any component or subassembly that does not meet Nipro specifications
- Reports all non-conforming materials to lab supervisor or lab QSM

**Identify and report all incidences**
- Be familiar with procedures that must be followed in the cleanroom
- Any standard procedure that cannot be followed will be reported as an incident to lab supervisor or lab QSM

**Jobs in progress**
- Clean the work space before beginning a job
- Clearly identify the job under their control, including product codes, subassembly codes and amount to be assembled, as well as that all components are accounted for.
- Organize the job in a tidy fashion
- Ensure they work only with components accepted for use
- Identify the correct trolley, with the correct components and the safe and orderly transfer of those components to their work station
- Review the schematic, work instructions, in-process inspection form and any pictures available for the job & prototype assembly
- Build prototype and have it approved before going on with the job
- Build sub-assembly properly
- Ask for any additional information (from Cannula lab supervisor) as needed to ensure correct completion of the task

**Production**
- Assemble cannula on a work order in appropriate sequence and machinery
- Report any equipment problems to Cannula lab supervisor or QSM
- Read and understand schematics
- Report any issues with interpretation of schematics to the Cannula lab or QSM supervisor
- Refer to schematics or inspection sheet for ALL directions
- Identify components and only use identified components in the assembly of the device
- Make connections properly and understand the use and the amount of bonding agents identified on the sheets
- Assist in developing new production methods and efficiency studies on the assembly procedure
- Follow Quality Management System under the ISO13485 standard
- Log each job in and out of ERP system

**Cleaning**
- All assemblers will be trained in proper Cannula lab entry
- Document training regarding appropriate type of under garment to wear, proper downing of uniform provided before entering Cannula lab

Tuck hair properly under head cover

No jewelry or lipstick, makeup or other artificial skin cover

No chewing gum, drinks or food in the Cannula lab
- Understand the nature of and purpose behind good work habits while in the Cannula lab
- Understand the purpose of and participate in the cleanliness and cleaning of the Cannula lab

**Health and Safety**
- Report any sickness or other medical condition that might impact the microbial contamination of the Cannula lab to the lab supervisor or QA coordinator
- Read and fully understand all equipment operation work instructions
- Use caution when operating lab equipment, ensuring fingers do not get trapped in the machines
- Use caution when operating grinders, tube cutter, air gun, printer, puncher
- Use safety equipment when processing chemical agents/operating equipment, read material safety data sheet (MSDS), and following safety practices

**Education & Certification Requirements**:
High school diploma or equivalent

**Experience & Required Skills**:
Previous experience in the medical or pharmaceutical manufacturing/assembly environment strongly preferred

Ability to perform high precision work and maintain stringent cleanliness requirements

Proven ability to work efficiently and cooperatively in a team, as well as being able to work independently

Proven ability to comprehend and interpret the product schematic, specification procedure and work instructions

Fluent English reading and writing skills

Detail oriented and punctual

Willing to learn new skills

Good vision (to detect product non-conformance)

Good manual dexterity

Able to sit for long periods of time

**EEO Statement**:
Nipro Canada Corporation provides equal employment opportuni