Position Summary: Work directly with customers and suppliers to quickly address quality related issues. Responsible for the day to day execution of core quality processes under the supervision of the Senior Quality and Compliance Leader.
- Participate in all aspects of the QA job function, e.g. processing of complaints, quarantines, customer recovery and advisories, change notifications, customer surveys, quality certificates, internal audits, generation of supplier and team metrics, etc.
- Process the download and distribution of complaints daily. Identify those complaints requiring escalation. Work with customer service to fully document the customer’s allegation and facilitate the return of product to be evaluated. Coordinate investigations with suppliers, and communicate root cause and corrective actions to customers.
- Coordinate investigation of quality issues with customers and suppliers. Review, approve and communicate root cause and corrective action to stakeholders.
- Facilitate the quarantine, recovery and disposition of products including those that may be sensitive in nature for regulatory or legal reasons.
- Collect and analyze quality data and prepare and distribute quality reports.
- Create and revise QA procedures and work instructions.
- Participate in internal audits of the Quality Management System.
- Participate in continuous improvement of core processes, using Practical Process Improvement (PPI).
- Represent the QA function and provide training as required to functions outside of QA.
- Assist with Notified Body and regulatory agency compliance reporting requirements.
- Act as Project Lead for Department project planning for current and future systems and their enhancements and updates.
- Execute projects and complete other duties as assigned.
- 5+ years of experience working in an ISO (9001 and 13485) and/or regulated environment.
- Bachelors Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics.
- Excellent oral and written communication skills.
- Experienced in a continuous improvement methodology and related analytical tools, e.g. Six Sigma, PPI, Lean, Minitab, Corrective and Preventive Action (CAPA), run charts, flow charting, Pareto charts, pivot tables etc.
- Strong attention to detail, ability to multi-task, customer focused and a flexible team player.
- Experienced in dealing with customers, suppliers, and senior management.
- Strong computer and analytical skills, including: data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint, and Data Warehouse tools.
- Experienced internal and external auditor, lead auditor experience preferred.
- Experience working with or administering a quality information management system, Master Control preferred.
Non-Negotiable Hiring Criteria:
- Knowledge of ISO Certification requirements including ISO 13485 and ISO 9001.
- Knowledge of Health Canada regulations.
- Skilled at root cause analysis and problem solving with a results orientation.