QMS Specialist - Amico Accessories
Amico
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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 www.amico.com
*Only selected candidates will be contacted.
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 www.amico.com
*Only selected candidates will be contacted.
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