Amico Group of Companies

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 non-conforming processes are captured and assessed using a risk-based approach, root-cause 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 problem-solving, analytical and decision-making skills.
Excellent attention to detail.
Excellent organizational, time management and multi-tasking 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

For more information, please visit us at www.amico.com

*Only selected candidates will be contacted.

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Quality & Regulations Associate - Amico Clinical Solutions