Quality & Regulations Associate - Clinical - Richmond Hill, Canada - Amico

Amico
Amico
Verified Company
Richmond Hill, Canada

1 week ago

Sophia Lee

Posted by:

Sophia Lee

beBee Recruiter
Description

Quality Assurance & Regulations Associate - Amico Clinical Solutions

Richmond Hill, ON


Would you like to work for a global company that is dedicated to personal career growth? Amico Corporation is a leading manufacturer of Medical Equipment with 9 manufacturing facilities employing over 1100 people across North America.

We are currently seeking a Quality & Regulations Associate to join our QC team


The Quality & Regulations Associate assists in ensuring that all processes and procedures are captured and comply with regulatory and accreditation standards.


Responsibilities:


  • Interpret and incorporate regulatory and accreditation requirements into new and existing procedures.
  • Ensure all processes and procedures are compliant with Health Canada Medical Device regulatory requirements.
  • Ensure all processes and procedures comply with all other accreditation requirements.
  • Assist in maintaining the Quality Management System.
  • Assist in maintaining the Quality Manual.
  • Ensure all nonconforming processes are captured and assessed using a riskbased approach, rootcause analysis and generate corrective and preventative actions.
  • Participate in internal and external audits.
  • Participate in regulatory/accreditation audits.
  • Continuously seek continuous improvement opportunities.
  • Ensure adherence to current processes and procedures as well as health and safety guidelines.
  • Provide training and assistance to all staff regarding process, procedures and QMS requirements.
  • Other duties as assigned by the Quality Assurance & Regulations Manager.

Qualifications:


  • Experience with Health Canada, ISO, TUV SUD and UK MDR requirements.
  • Excellent written and verbal communication skills.
  • Excellent interpersonal skills.
  • Excellent problemsolving, analytical and decisionmaking skills.
  • Excellent attention to detail.
  • Excellent organizational, time management and multitasking skills.

Education and Experience:


  • 2+ years in Quality Assurance in similar field
  • Bachelors in a science related field
  • Certification in Lean Six Sigma
  • Certification in relevant Quality fields
More jobs from Amico
See all jobs of Amico