POSITION TITLE:

Quality Specialist (12 month maternity leave contract)

REPORTS TO:

Director of Operations and Quality Assurance

Location:

Richmond Hill, Ontario

PRIMARY FUNCTION:

The Quality Specialist is responsible for working with the Director of Operations and Quality Assurance on developing and maintaining a quality management system to comply with Canadian Medical Device Regulations and ISO requirements. 

To help maintain certain quality and efficiency standards and contribute to continuous improvement efforts in production.  Adhere to all safety requirements.  Assist in training others on skills required for assigned areas.

AREAS OF RESPONSIBILITY AND AUTHORITY:

To drive operational compliance to Quality Management System standards (ISO13485 and MDSAP) as well as contractual and regulatory requirements.Analyze field return data and present in a meaningful manner.Root cause analysis and implementation of corrective action for process related concerns.Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.Help conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.Assist in establishing, implementing and maintaining the quality management system.Develop and implement methods and procedures for the disposition of non-conforming material.Help with the incoming material quality control system.Act as Deputy Management Representative for Quality Management SystemWorking with US Quality and Operations on cross site Quality requirement.Develop, maintain, communicate and enforce QC programs and standards. Assist with handling of customer complaints and ensuring timely follow through. Identify and maintain quality and legislative requirements by adhering to and enforcing Good Manufacturing Practices and Standard Operating Procedures.Take corrective action on internal and external rejects.Support and/or act as SFDC Administrator in maintaining the Complaint Handling process.Research, analyze data and provide trending reports utilizing manufacturing and quality systems; such as Navision and Salesforce.com.Generate regular production quality reports for both internal and offshore productionManagement of the KPI’s across Production and LogisticsMaintain and manage training Matrix and training records in Production and LogisticsHelp with the creation and maintenance of the Quality documents in the QMSFollow up on outstanding CAPAs and Non-Conforming Report actions within Production and Logistics.Auditing existing process against procedures and work instructionsPerforming any other reasonable duty as may be required from time to time to ensure the smooth and efficient running of the quality management system.Ensures all documentation in production is updated and accurate and help train operators, if required.Responsible for maintenance and internal calibration of all equipment and building infrastructure.Maintains chemical supplies and ensuring proper disposal, updating the SDS binder as required.

EDUCATION:

University degree or College degree in Process Engineering or Regulatory, or equivalent work experience in Audiology

EXPERIENCE:

Minimum of 3-5 years of relevant work experience with quality management systems, quality tools and process analysisUnderstanding of ISO 13485 and Canadian Medical Device Regulations, Direct experience in Medical Device Manufacturing.Hearing Instrument Specialist experience is considered an attractive bonus in this role, but not required.

KNOWLEDGE SPECIFICATIONS:

Problem solving skills / Critical Thinking skillsStrong communication skills, both verbal and writtenSelf-directedExcellent organizations skillsDetail oriented

PHYSICAL REQUIREMENTS:

None.

WORKING ENVIRONMENT:

Office and Production Environment.