Quality Manager - Rockton, Canada - McArthur Medical Sales Inc.

McArthur Medical Sales Inc.
McArthur Medical Sales Inc.
Verified Company
Rockton, Canada

3 days ago

Sophia Lee

Posted by:

Sophia Lee

beBee Recruiter
Description

McArthur Medical Sales is committed to providing safe and effective medical devices that meet customer needs through the establishment, maintenance, and communication of a Quality Management System compliant with applicable regulatory bodies.

The Quality Objectives, Quality Policy, Quality Management

Procedures, and Quality Manual are established, maintained, and communicated in order to continually improve upon our risk-based process approach.

Established in 1984, McArthur Medical is a Canadian leader in medical devices for neonatal, anesthesia, and respiratory care. Our MMSI team is looking to add individuals that look forward to working in a fast
- paced environment.


Responsibilities:


  • Certify the Quality Management System (QMS) is implemented, followed and updated as required to ensure procedures are observed.
  • Establish and maintain records, ensure that the QMS is being followed, continue to follow current organized system for the storage, protection, retrieval, retention time, identification and disposition of records.
  • Lead a team of individuals responsible for quality control and complaint handling.
  • Follow all regulatory requirements in accordance with Health Canada, FDA, ISO Ensuring all quality systems are implemented and defined.
  • Oversee and provide assistance for documents control, change control, Corrective Actions
(CAPA) and NCRs.

  • Establish quality meetings with all required staff.
  • Oversee customer complaint log and internal investigations.
  • Update and renew medical device licenses and any other required documents
  • Complete internal audits and supplier audits.
  • Coordinate with engineering team with regards to new projects and modifications with regards to risk analysis, verification, validation and design.
  • Perform reviews of QMS at scheduled dates to verify effectiveness, suitability and adequacy.
Assess if changes or improvements are necessary.

  • Lead and prepare for all required audits by regulatory agencies.
  • Administer all required training for new hires as related to their role and responsibilities within the company as it relates to the QMS. Provide training and testing as necessary.
  • Moderate the quality system, inbound inspections and supplier management to ensure proper improvements are completed as required.

Qualifications:

  • Bachelor's degree or equivalent experience in applicable industries.
  • 3+ years of experience as a Quality Manager.
  • Excel in critical thinking with accuracy.
  • Experience with Health Canada, FDA and Medical Regulations ISO 1348
  • Computer skills with the ability to learn inhouse related software.
  • Selfmotivated individual
  • Excellence communication skills
  • Be able to multitask set priorities to meet deadlines
  • Work independently or as part of a team
  • Strong people skills
Salary

  • From $80,000+ per year
Job Type

  • Fulltime Permanent

Work Location:
One location - In office


Benefits:


  • Extended Healthcare
  • Dental Care
  • Disability Insurance
  • Life Insurance
  • Tuition reimbursement
  • Paid time Off
  • Onsite parking
Schedule

Monday - Friday 8:30-4:30


Job Types:
Full-time, Permanent


Salary:
From $80,000.00 per year


Benefits:


  • Casual dress
  • Dental care
  • Disability insurance
  • Extended health care
  • Life insurance
  • Onsite parking
  • Paid time off
  • Tuition reimbursement

Schedule:

  • Day shift
  • Monday to Friday
  • No weekends

Ability to commute/relocate:

  • Rockton, ON: reliably commute or plan to relocate before starting work (required)

Education:


  • Bachelor's Degree (preferred)

Experience:

- quality assurance: 1 year (preferred)


Work Location:
One location
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