Quality & Regulations Associate - Amico Clinical

5 days ago

Richmond Hill, Canada Amico Full time

**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

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