The Quality System Assistant supports the Quality Systems Manager in all aspects of the quality system operations. The primary function will require the internal auditing and daily maintenance/review of the quality system processes to ensure compliance and improvements to the system.
- Performs internal audits of the quality system processes
- Assesses compliance to regulatory requirements including ISO: 13485/ISO 22442-2/FDA CFR: 820/MDD/HC-CMDCAS and other jurisdictions as required
- Provides detailed auditing reports of the trends, issues and provides evaluation of the level of compliance to the processes audited
- Initiates audit N/C reports and provides corrective and preventative action support
- Maintains annual audit schedules and communicates with departmental personnel on planning of the audits
- Analyses and maintains processes to ensure compliance, effectiveness and improvements to the quality system
- Monitors Non-Compliance and CAPA issues and ensures the actions are implemented within agreed time frames
- Follow up verification and effectiveness of actions activities completed
- Commitment to working effectively and cooperatively with all personnel
- Provide administration assistance with all quality related projects and duties; including regulatory affairs, engineering and production and including customer complaints and general maintenance of the quality system
- Works with document control on related document reviews and amendments
- Assists the QSM with notified body (ISO/FDA/MDD/HC) and customer audits
- Helps personnel from other departments on quality issues
- Supports other activities not related to audit findings where non-conformance and corrective/preventative actions are raised
- Helps with changes in regulatory requirements that impact upon the quality system.
- Assists with audits of third party manufacturing locations, suppliers and contractors as needed
- Work with the QSM on customers corrective actions and improvement initiatives related to their products
- Provides input details for yearly management reviews, compiling information on quality system compliance and issues, trend evaluations
- Participates in quality meetings covering the quality system including CAPA’s, N/C’s, audits, and associated compliance activities and projects
- Supports inter-departmental training initiatives and training of personnel
- Follow up to training and verifies compliance through follow-up checks and ongoing training to reemphasis system requirements
- Assists with other Neovasc related processes as required
- Minimum 2 years of post-secondary education in a related discipline or equivalent combination of education and experience.
- Certified auditor
- 3 -5 years experience performing quality system audits in a medical device and manufacturing environment.
- Experience establishing compliance with ISO regulations
- Previous experience working with, and improving, company procedures/SOP.
- Experience auditing company operations compliant to ISO13485: 2003 (or similar) within a manufacturing/medical environment.
- Knowledge of current medical device regulatory requirements (Health Canada, EU CE Mark and FDA).
- Knowledge of basic validation concepts.
- Strong analytical and problem-solving skills.
- Use of initiative, self-motivation, planning and organizational skills.
- The ability to work effectively and interact daily in a cross-functional setting.
- Knowledge of medical device QS standards (ISO13485:2003).
Indeed - 13 months ago