Position Title: Mechanic and Machine Maintenance
Position Type: Full-time, permanent, hourly
Shift: Day (7:00 am to 3:30 pm), Afternoon (3:00 pm to 11:30 pm), Night (11:00 pm to 7:30 am)
Division: Production
Location: Cambridge, Ontario
Start Date: 1-2 weeks

Departmental Overview

PRIMED Medical Products Manufacturing Ltd.’s (“PRIMED Cambridge”) Production team is dedicated to the manufacturing of the highest quality medical devices that will deliver on our mission: to protect people from harmful substances and infectious disease. This includes responsibility over all aspects of the product from raw material to finished goods while adhering to safety protocols, manufacturing best practices, and PRIMED’s Quality Management System.

Position Function

The Mechanic and Machine Maintenance (Mechanic) is detail oriented, focused and takes pride in the work completed in a fast-paced, high speed environment. As part of the manufacturing process, the Mechanic is responsible for ensuring proper functioning of the various production machines, installation and assembly of new machines and equipment, adjusting and repairing equipment, calibration, and proactively performing maintenance to ensure it operates at peak efficiency. When new lines come onboard, the role will require setup and operation testing of the line machine based off the experience and training provided by the China counterparts. Adjustments and unjamming the machine to meet different specifications will be required and a commitment to high response rate and uptime is critical.

Working Relationships

The Mechanic will report to the Plant Manager with initial training provided by experienced Mechanics from PRIMED’s Asian facilities. Machines imported from PRIMED’s China plants will be configured using PRIMED’s proprietary knowhow and will require interacting with the Chinese counterparts. Communication with fellow team members and production staff will ensure continuous and reliable production of the correct product at the correct specifications. Mechanics will demonstrate patience and a coaching attitude to educate and train Operators.

Responsibilities

The following is a list of the high-level activities or deliverables with the goal to maximize production equipment efficiency and reduce waste to the manufacturing line through process efficiencies:

• Setup, installation, and testing using PRIMED’s internal processes and procedures new lines or machines, as required
• Responsible for addressing live stoppages and performing preventive/predictive maintenance.
• Installations of new equipment
• Coordinate safety inspections and regulatory compliance following ESA, PSHSR and TSSA.
• Check, adjust and repair various systems including:
  • Welding roller
  • Ultrasonic welding systems
  • Changing of electrical boards
• Cleaning, lubricating and performing other routine maintenance work on machines
• Mechanical troubleshooting and ongoing maintenance based on maintenance schedule
• Keep detailed and accurate maintenance report and documentation
• Root cause analysis within a Quality Management System
• Documentation and training of repair procedures
• Follow all plant rules and safety regulations
• Support Plant Manager with special projects and work flow improvements, as required.

Working Conditions

Attention is shifted from one job task to another frequently during the day. This is a hands-on role; therefore, time and priority management abilities in addition to excellent communication skills are essential. Other conditions and requirements of the role include:

• Accuracy, attention to detail and the ability to multi-task
• Calm and hard working with an analytical mindset
• Must wear all Personal Protective Equipment (PPE) supplied
• Lifting, moving and stacking 10-40 lbs (e.g. raw material roll on machine)
• Ability to read English, Work Instructions, Manuals, and other documents
• Experience as a machine operator in a fast-paced environment is an asset
• Able to deal with people sensitively, tactfully, diplomatically, and professionally
• Work independently, self directed, and collaborate in a team environment.

Qualifications

• Must be legally eligible to work in Canada and be a minimum age of 18 years old
• Licensed millwright
• Ability to read and write English and communicate effectively with teammates
• Positive attitude and willingness to develop new skill as manufacturing increases
• Highly flexible and eager to learn
• Working knowledge of safety standards of equipments
• Attention to detail and ability to find defects or methods of improvement
• Ability to work in a start up like environment with growth and evolution on the horizon.

Hours of Work

The Mechanic and Machine Maintenance position is a permanent full-time position with a day, afternoon, and night shift available. Some overtime may be required and will be discussed and agreed upon in advance.

How to Apply

This position is available immediately. Interested applicants may submit their cover letter and resume in a single document via Indeed. Please state which shift(s) you are available for.

Due to the COVID-19 pandemic, responses to applicants may be delayed. We thank all applicants for their interest. Only those chosen for an interview will be contacted.

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Position Title: Inventory Clerk
Position Type: 1 year contract, full-time
Division: Operational Excellence, Inventory and Distribution
Location: Edmonton, Alberta
Start Date: November 2020

Division Overview

The Operational Excellence Division encompasses various departments including Operations (Supply Chain, Customer Service, Operations Planning), Information Technology, Strategic Sourcing, and provide guidance to international Operations. The Operations team is responsible for all aspects of supply chain and logistics operations including strategy, planning and execution for all Canadian sales while providing world class customer service.

Position Function

The Inventory Clerk is responsible for ensuring a smooth inventory management and distribution operations within the company. This includes having accurate information within PRIMED’s various inventory systems and ensuring it is communicated to the various team members including Accounting and Sales. As a key member of PRIMED’s success, the role requires exceptional communication skills, team involvement, interpersonal skills and professionalism in order to perform day to day job tasks. The Inventory Clerk will play a critical role in meeting customer demands and delivering on PRIMED’s mission: to protect people from harmful substances and infectious diseases.

Working Relationships

The Inventory Clerk reports directly to the Manager, Inventory and Distribution Operations and has close internal working relationships with Operations, Finance and all other PRIMED departments.

Outside of the organization, the Inventory Clerk is in direct contact with Warehouse Staff, Customers, Distributors, 3^rd Party Logistics providers and Freight Companies. The main purpose of this contact is to obtain, explain and exchange information, problem solving and interpreting/resolving conflicts.

Responsibilities

The following is a high-level description of the Inventory Clerk’s responsibilities and is not mean to be all-inclusive:

• Reviews packing lists with receiving paperwork to verify they match
• Advises the warehouse of any discrepancies made in the receiving paperwork
• Reviews vendor invoicing for accuracy and reports discrepancies to suppliers
• Receives inventory containers into the Enterprise Resource Planning (ERP) system
• Works with the Accounting department to resolve any issues that may arise regarding invoice and inventory receiving discrepancies that relate to Canadian operations activities
• Generates invoices for all items shipped Less than Truckload (LTL) or direct container and provides Customers and Distributors with electronic copies
• Files corresponding electronic communications in specified folders in Outlook/shared drive
• Processes POs and creating inventory releases in the Order Entry system for Quality Assurance (QA) samples
• Electronically submits inventory releases to appropriate 3^rd Party Logistics warehouses for QA samples
• Assist with annual inventory counts at PRIMED warehouses and locations
• Logs incidents and Customer complaints in the Service Incident database and follows up with applicable departments to ensure resolution and closure
• Processing damage claims for LTL shipments
• Reviewing 3PL and carrier invoicing for accuracy and resolves discrepancies with the vendor
• Responds to inquiries regarding current in-stock items, pricing and sales history
• Supports the Manager as needed with inventory control, including transfers, new business incorporation, and old product rotation, and physical inventory counts
• Other duties as required.

Working Conditions

Attention is shifted from one job task to another frequently during the day. Therefore, time and priority management abilities in addition to excellent communication skills are essential for this position. Accuracy, attention to detail and the ability to multi-task are key success factors.

Examples of mental effort include:

• Completing reports and updating documents
• Revising Container purchase orders
• Multi-tasking abilities and time management skills are required for this position
• Interruptions come from requests for assistance or new tasks as directed
• Concentration, computer skills, assembly skills, reading comprehension, personnel skills, etc.
• Communicating with Warehouse Staff, Customers, PRIMED Staff, Distributors, 3^rd Party Logistics Providers and Freight Companies

Valid travel documents and the ability to travel to various jurisdictions legally is a requirement of the position.

Examples of physical effort include:

• Working in a seated position at a desk, more than 6-7 hours per day
• On occasion, lifting a box or other objects up to 40 lbs, as required
• Occasional product pick-ups and/or delivery to Customers or staff, as required.

The ability to use computers and equipment effectively and accurately in a timely manner is required.

Qualifications

Given the critical role this individual will be expected to play in delivering on PRIMED’s mission, it is essential that the successful candidate possess the following core competencies, experience and attributes:

• University or College diploma/degree or equivalent experience
• Canada Customs or supply chain management training would be considered an asset
• Working knowledge of accounting software such as Sage 300 would be considered an asset
• Previous related working experience, preferably in a supply chain environment
• Intermediate to advanced computer proficiency in a Windows based environment using Word, Excel, Access, and Outlook
• Ability to create and modify documents and complex spreadsheets
• Ability to read, understand and interpret such things as reports, shipping documents, and procedures and manuals
• Ability to write reports, procedures, correspondence, and insurance claim forms
• Excellent written and verbal communication skills
• Attention to detail and accuracy are key requirements
• Organized, with excellent time management skills.

Other Assets

• Ability to write reports, procedures, correspondence, and insurance claim forms
• Working knowledge of accounting software such as Sage 300 would be considered an asset
• Excellent written and verbal communication skills
• Attention to detail and accuracy are key requirements
• Organized, with excellent time management skills.

Hours of Work

This position is based in Edmonton and typical office hours are Monday to Friday, 8:00 a.m. to 4:30 p.m., however work outside of these hours may be required from time to time and will be discussed in advance.

How to Apply

This position is available immediately. Interested applicants may submit their cover letter and resume to our recruiting partners at Randstad Edmonton who are administering the recruitment.

Please apply directly to the posting on the Randstad website at: https://www.randstad.ca/jobs/inventory-clerk-1-year-contract_edmonton_2236955stfen/

Or directly to melissa.tkachuk@randstad.ca with the subject line "Inventory Clerk".

Due to the COVID-19 pandemic, responses to applicants may be delayed. We thank all applicants for their interest. Only those chosen for an interview will be contacted.

Note:  This job posting is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

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WAREHOUSE ASSOCIATE
The Warehouse Associate is a key member of the facility and works very closely with Warehouse Coordinator and every member of the team. They will unload, record, and move safely to the storage location all incoming raw material shipments. During production, they will also work with the production team and pull any materials required. The safe movement of raw material and finished goods is paramount for the Warehouse Associate. After moving the product from production to warehouse, they will perform a cycle count, pull orders, and ensure efficient storage of finished goods. While the work is labourious, they will take pride in the work completed because they ensure delivery of our product to the end-user.

QUALITY CONTROL LINE INSPECTOR
The Quality Control (QC) Line Inspector is a hands-on team player and is responsible for performing and completing tasks and requirements according to prescribed work instructions, inspection plans, or specification verification. This role applies the Quality Management Systems (QMS) on a daily basis to ensure high-quality products reach our customers. They will be very detailed oriented in the inspection process including documentation, records, and finished products. They will perform critical testing according to various established work instructions while interpreting and recording data into the QMS system. By providing evidence of results to the QC Supervisor, the QC Line Inspector will actively participant in production of products and continuing to improve and optimize PRIMED’s world-class quality.

PRODUCTION OPERATORS
The Production Operator is detail-oriented, focused and takes pride in the work completed in a fast-paced, high-speed environment. As part of the manufacturing process, the Production Operator is responsible for ensuring proper operation of their machine and proactively taking actions to ensure it operates at peak efficiency. The role will require setup, loading, and operation of the line machine with the established procedures and guidelines. Adjustments to the machine to meet different specifications will be required and a commitment to a high-quality output, with minimal wasted materials and time is key.

PACKER
The Packer is a key member of the Production team and carries out the final packing of finished cartons into shipping cases. They will move quickly and takes pride in the work completed in a fast-paced, high-speed environment. As part of the final stage of the manufacturing process, the Packer is responsible for moving the finished cartons (inner box) of product from the production line into the packing area. There they will perform packaging related tasks like placing empty cases onto conveyors, operating taping machines, and manually packing goods into cases. The role will require setup, loading, and operation of the packing machine with the established procedures and guidelines. Adjustments to the machine to meet different specifications will be required and a commitment to high quality with minimal wasted materials and time is key.

MECHANIC AND MACHINE MAINTENANCE
The Mechanic and Machine Maintenance (Mechanic) is detail-oriented, focused and takes pride in the work completed in a fast-paced, high-speed environment. As part of the manufacturing process, the Mechanic is responsible for ensuring proper functioning of the various production machines, installation of new machines and equipment, adjusting and repairing equipment, and proactively performing maintenance to ensure it operates at peak efficiency. When new lines come on board, the role will require setup and operation testing of the line machine based on the experience and training provided by the China counterparts. Adjustments and unjamming the machine to meet different specifications will be required and a commitment to high response rate and uptime is critical.

HOW TO APPLY
If you’re interested in any of the roles, please reach out to our employment partner Randstad Canada Staffing. Carrie Hamer can be reached at 519-740-6944 Extension 1 or Carrie.Hamer@randstad.ca.

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Position Title: Quality & Regulatory Affairs Associate
Position Type: Permanent, full-time
Division: Quality & Regulatory Affairs
Location: Edmonton, Alberta
Start Date: November 2020

Departmental Overview

The Quality and Regulatory Affairs department is responsible for ensuring product meets customer and regulatory requirements in the jurisdictions in which the product is sold. The department also ensures the company’s Quality Management System is maintained and meets the requirement of ISO 13485:2016 MDSAP.

Position Overview

The Quality & Regulatory Affairs Associate (QRAA) oversees and/or assists in maintaining certain programs within the Quality Management Systems (QMS) including Document Control, Training, NCR and Corrective Action/Preventive Action (CAPA) programs. This position ensures that these programs are functioning effectively with proper tracking, communication and documentation/records. In addition to these programs, the QRAA is involved in supporting change control and regulatory activities.

Overall the Quality & Regulatory Affairs Associate assists in ensuring that the programs stated above, as well as the completion of any activities are in compliance (i.e., meeting regulatory requirements, ISO 13485/QSR, and overall customer satisfaction).

Working Relationships

The QRAA is a member of the Quality Team and reports to the Senior Manager, Quality and Regulatory Affairs (SMQRA). The QRAA will work primarily with and under the instruction of the SMQRA. The QRAA will also work with the Quality Assurance Specialist (QAS), Regulatory Affairs Specialist (RAS) and all departments at PRIMED to ensure the corresponding QMS programs are functioning effectively.

External relationships may include vendors (i.e., for CAPAs), customers, and auditors. The nature of this interaction is dependent on the issue/topic at hand.

Responsibilities

Document control, records management, and compliance with guidelines, procedures, and regulatory requirements is a key component of the quality driven activities including:

• Coordinates and manages the QMS Training and QMS Document Control program for the company
• Perform artwork verification on post production product
• Review and approves product artwork and specification
• Supports in-house testing of products
• Supports the maintenance of databases and record retention
• Reviews Certificates of Analysis, Certificates of Conformance, Inspection Reports
• Supports other company Quality Programs including:
  • Rework, Vendor Management, Customer Feedback, Deviation and Quarantine
• Maintains appropriate communication (i.e., databases, meetings, follow-ups)
• Develops strategies for continuous improvement of the quality system
• Other tasks as directed by the QAS, RAS and SMQRA.

Working Conditions

Examples of mental effort include: concentration, computer skills, technical skills, reading comprehension, personnel skills etc.

Attention is shifted continuously from one job detail to another. Occasional interruptions come from requests for assistance. Multi-tasking abilities and time management skills are required for this position.

Valid travel documents and the ability to travel to various jurisdictions legally is a requirement of the position.

Examples of physical effort include:

• Working in a seated position, at a desk 6-7 hours/day
• On occasion, lifting a case or other objects up to 40 lbs, as required.
• Occasional product pick-ups or delivery to Customers or staff, as required.

The ability to use computers and equipment effectively and accurately in a timely manner is required.

The ability to travel domestically and internationally may be required.

Qualifications

• Post-secondary education or equivalent
• 1 - 3 years on the job experience within a quality management system, preferably with medical devices
• Knowledge of ISO 13485, medical device regulatory affairs and quality system regulations, etc. is an asset
• Demonstrated exceptional organizational skills
• Excellent information tracking and communication skills (i.e., database management)
• Intermediate to advanced computer proficiency in a Windows based environment, working with Word, Excel, PowerPoint, and Outlook
• Good communication skills, both written and oral

Hours of Work

The QRAA position is a permanent full-time position with typical working hours being Monday to Friday, 8:00am – 4:30pm. Some travel may be required. Some overtime may be required.

How to Apply

This position is available immediately. Interested applicants may submit their cover letter and resume in a single document via the application form on www.PRIMED.ca/Careers.

Due to the COVID-19 pandemic, responses to applicants may be delayed. We thank all applicants for their interest. Only those chosen for an interview will be contacted.

Note:  This job posting is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

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