#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

Please apply directly to:

Mitchell Cherry

Quality Assurance Manager

Email: mcherry@ldtool.com

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