Qms Specialist

3 months ago

Richmond Hill, Canada Amico Full time

**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

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