QMS Specialist - Richmond Hill, ON, Canada - Amico Corporation

Amico Corporation Richmond Hill, ON, Canada

1 week ago

Description

QMS Specialist – Amico Accessories
Richmond Hill, ON

Would you like to work for a global company that is dedicated to personal career growth? Amico Corporation is a leading manufacturer of Medical Equipment with 9 manufacturing facilities employing over 750 people across North America. We are currently seeking a QMS Specialist to join our QC team
Qualifications:

Expert in Health Canada and FDA regulations, and ISO 13485:2016, and associated ISO standards
Author and review SOPs, policies to ensure compliance and adherence to Health Canada, FDA, and ISO 13485:2016 requirements
Extensive understanding in writing Operating Procedures, and creating a QMS system with great details for daily operations
Experienced in Internal Audits for ISO 13485:2016 and MDSAP
Work with developers to produce quality documentation and training materials
Under general direction, write technical copy for various type of documents for a program/project of similar complexity
Control and distribute work instructions, forms, and logs in all departments
Prepare and maintain operations documentation, user guide and manuals and technical publications
Responsible for coordination, implementation, and maintenance of QA program
Develop outlines and drafts for review and approval by technical specialists and project management
Develop others and ensure training and learning of team members
Provide internal training to ensure QA standards are taught and implemented
Support implementation of cost, quality, and service improvement initiatives
Develop and maintain cooperative and courteous relationships with fellow employees

Responsibilities:

Bachelor's or Graduate's Degree in Science, Engineering, or English, or equivalent experience
Proficient in written, spoken, and reading skills in English
Exceptional abilities in technical writing
Experienced with Microsoft Word and Office
Demonstrated expertise in intricate process mapping and crafting procedures for multi-departmental workflows
Expert in creating a QMS systems with Operating Procedures and Work Instructions with great details
Highly organized and detail-oriented
Capable of thriving in a fast-paced and time-sensitive work environment
Expert in Health Canada and FDA medical device regulation is a must
Expert in ISO 13485:2016 and MDSAP is a must
Expert in Internal Audit for ISO 13485:2016 and MDSAP is a must

For more information, please visit us at *Only selected candidates will be contacted.
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