Quality Manager

2 weeks ago

Richmond Hill, Canada Amico Full time

**Quality Manager - Amico Clinical Solutions**

**Richmond Hill, ON**

The Amico Group of Companies develop medical products that enhance the quality of life and well-being of people all over the world. Amico is growing rapidly as a result of the introduction of many new and innovative products into the marketplace. We are looking for individuals who are excited by a challenge and thrive in a fast-paced environment.

Join the Amico team if you want to work for a company at the forefront of the healthcare industrya company that cares about its employees, its customers and its products.

**Responsibilities**:

- Ensure that the processes needed for the Quality Management System (QMS) are established, implemented, adhered to and updated as required.
- Manage a team of quality personnel in the tasks of inbound QC, outbound QC, and complaint handling.
- Implement and define the quality systems in accordance with regulatory requirements (Health Canada, FDA, ISO).
- Management Representative for the APC QMS
- Provide support and oversight of change control, documentation control, NCRs, and Corrective Actions (CAPA)
- Create, collect and analyze Quality Key Performance Indicators (KPI) to identify actionable trends.
- Coordinate monthly quality meeting
- Coordinate continuous improvement in the quality system, inbound inspections, supplier management, inline inspections
- Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records.
- Support engineering team during new designs and modifications in during such stages as risk analysis, design review, verification and validation.
- Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide updated training and documentation as necessary.
- Ensure that the performance of the QMS is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness. This review means assessing opportunities for improvement and the need for changes to the QMS.
- Manage Customer Complaint Log and investigations.
- Prepare for and attend scheduled audits by regulatory bodies.
- Renew and manage medical device licenses and registrations.
- Write, revise and update SOP, work instructions and Quality Manual as necessary
- Coordinate and perform internal and supplier audits.

**Qualifications**:

- Bachelor’s degree or equivalent experience in a relevant field
- 3+ years of experience as a Quality Supervisor/Manager is a must.
- Educational background in Quality Assurance
- Experience with Medical regulations ISO 13485, Health Canada, FDA
- Strong critical thinking, high level of accuracy
- Experience in manufacturing
- Experience in support and troubleshooting
- Must be able to manage priorities and meet deadlines
- Ability to work independently as well as part of a team
- Must possess excellent communication skills and be self-motivated
- Proficient computer and math skills and ability to learn new software

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