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Quality Assurance Engineer
SciCan —Toronto, ON
This position will be responsible for executing a range of quality assurance activities, including but not limited to; managing the calibration and maintenance…

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Quality Assurance Engineer

SciCan
Toronto, ON

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Détails du poste

Compétences

SAP
Ingénierie
Systèmes PGI
Microsoft Office
Esprit d'analyse
Capacités de présentation
Gestion des risques
Compétences en communication
Planification stratégique
Audit interne

Description complète du poste

Combining the spirit of achievement with human and social values has always been a priority at SciCan. Add to this our proven track record of innovation, high quality and dependability, and you’ll find a powerful combination that has ensured our growth as a company. We maintain our position as a leader in the health care industry by using a management structure that balances trusting relationships with a creative, dynamic environment.

Being a member of the SciCan family means taking an interest in exploring new paths and using your leadership and strategic planning skills. If you thrive in an exciting, active environment and value quality of life as much as quality of work, we’d like to hear from you. Feel free to send us your resume to [email protected] if you’re interested in pursuing an opportunity with SciCan in the future.

Quality Assurance Engineer

Job Summary

This position will be responsible for executing a range of quality assurance activities, including but not limited to; managing the calibration and maintenance program for tools and measuring equipment; coordinating and conducting final inspection procedures for finished products; monitoring and resolving open Temporary Deviation Notices (TDNs); and organizing training initiatives for newly onboarded personnel. This role plays a critical part in ensuring compliance with quality standards and supporting continuous improvement across the organization.

Core Competencies:

Communication
Problem Solving, Mathematical Reasoning
Teamwork
Result Focus
Quality Oriented
Accountability and Dependability
Time Management
Ethics and Integrity
Adaptability/Flexibility
Providing Consultation
Creative and Innovative Thinking
Enforcing Regulations
Decision Making and Judgement
Continual Learning
Planning and Organizing

Job Duties & Responsibilities:

Review, update, and maintain quality documentation including procedures, manufacturing instructions, and forms.
Oversee the Calibration and Maintenance Program for all tools and measuring equipment.
Notify relevant departments of upcoming calibration deadlines.
Coordinate the shipment and receipt of equipment with external test and calibration facilities.
Organize and perform final inspection activities for finished products in collaboration with QA personnel, in accordance with the production schedule.
Assist in validating production processes to ensure compliance and efficiency.
Facilitate supplier onboarding and manage periodic evaluations and re-evaluations.
Collaborate with cross-functional teams to address product quality concerns and support related initiatives.
Prepare and analyze production quality reports; investigate root causes of failures and recommend corrective actions.
Develop and manage training programs for the Quality Assurance department.
Conduct in-process inspections of finished products as scheduled.
Monitor and resolve open Temporary Deviation Notices (TDNs).
Develop and maintain various Quality departmental KPIs
Investigate customer complaints and coordinate root cause analysis.
Perform internal audits of the Quality Management System and supplier audits as required.
Provide support and backup coverage for QA team members.
Support various Quality projects as required
Execute additional tasks as assigned by the Quality Assurance Manager to uphold the Quality Management System and departmental objectives.

Educational and Experience Requirements:

Degree in Quality Engineering or Engineering Degree plus Quality Certificate
Minimum of 2 years related experience in a Medical Device manufacturing environment preferably with technology related products
Extensive familiarity with ISO 13485, preferably the 2016 version; MDSAP experience and application an asset; MDR experience is an asset
Internal auditing and risk management experience an asset
Strong communication skills both verbal and written
Ability to work in groups as well as independently with minimal supervision
Strong analytical and problem-solving skills are essential
Computer skills: MS Office, ERP (SAP preferred)
Proven ability to deliver presentations and training, effectively and efficiently with clear communication skills and delivery

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Je souhaite recevoir la dernière alerte emploi pour les postes de ce type : assurance engineer (columbus)

Quality Assurance Engineer

Job Summary

Core Competencies:

Job Duties & Responsibilities:

Educational and Experience Requirements:

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