#1 Customer Account Quality Specialist

• Preparation Date: February 28, 2022
• Reports To: Quality Assurance Manager
• Supervises: N/A
• External Relationships: Customers and suppliers
• Author: Mitchell Cherry

JOB SUMMARY

Function as the lead quality contact for a large customer account, ensure product quality and support QMS/customer/regulatory requirements in an ISO 13485 environment.

NATURE AND SCOPE

Duties and Responsibilities:

• Quality System Documentation conforming to ISO 9001 & 13485 standard
• Regulatory Requirements
• Internal Quality Audits
• Documentation related to batch records
• Lead supplier corrective action request (SCAR) responses, track actions to completion and verify effectiveness.
• Be quality lead and work with applicable personnel to complete FAI’s and validations for medical devices
• Review drawings, specifications and engineering changes to access compliance, impacts and risk
• Other duties as required

Skills and Abilities:

• Excellent organizational skills
• Communication skills written and verbal
• Statistical Analysis
• Excellent computer skills
• Judgment and Interpretation
• Proficient with 5s practices
• Knowledge of PPAP

Employment Requirements

• Educational Requirements: Post-Secondary education in a technical field
• Years of Experience: 5 + years experience in the Quality Assurance.
• Specialization Required: Must have working experience with ISO 9001 & 13485 and FDA GMP requirements

#2 moulding operators

There is no experience necessary as we train all new employees.

There are four shifts open for this position:

• Monday – Friday 4:00 pm - 12:30 am = $17.00 + $.50 Shift Premium
• Monday – Friday 12:00 am - 8:30 am = $17.00 + $2.00 Shift Premium
• Two week rotating schedule 7:00 am - 7:30 pm = $17.00 + $1.00 Shift Premium + Overtime
• Two week rotating schedule 7:00 pm - 7:30 am = $17.00 + $2.00 Shift Premium + Overtime

#3 Process Technician

Duties and Responsibilities:

• Proficiently set-up moulding machines from saved set ups and from scratch
• Perform First-off quality inspection at the start of each production run
• Trouble shoot processes to assure the production of product that meets all quality standards
• Set up and programming of injection moulding robotics
• Teach and mentor junior staff
• Keep all moulding equipment clean and notify maintenance of any repairs needed
• Notify toolroom of any deficiency regarding the moulds.
• Ensure all operations are carried out in a safe and efficient manner
• Keep shop floor organized and clean understanding of 5s principals
• Non-Conformance reporting

Skills and Abilities:

• 3-5 years of strong technical Process / Set up experience
• Excellent organizational skills
• Good English communication skills, both written and verbal
• Understanding of Windows, Excel, Word and email software
• Good knowledge of all materials used in an injection molding plant
• Problem solving and troubleshooting abilities
• Good judgment and interpretation skills
• Must be reliable, punctual with a good work ethic
• Quality and safety awareness

Effort:

• Mental and Physical stress

Educational Requirements:

• Will require on the job training, quality systems training and ERP training
• Grade 12 or equivalent

Years of Experience:

• 3-5 years of strong technical Process /Set up experience
• Knowledge of Engel machinery

Specialization Required:

• Forklift & Crane operator