Quality Systems Assistant
Neovasc Inc. - Richmond, BC

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Position
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.

Position Description

  • 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

Qualifications
Education:

  • Minimum 2 years of post-secondary education in a related discipline or equivalent combination of education and experience.
  • Certified auditor

Experience:

  • 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.

Skills:

  • 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 - 21 months ago - save job