QARA Specialist

How to Apply:

 

To apply, please send an email to ops@cosm.care. Please include the title of the position you are applying to in the subject line and attach your resume.

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Company:

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Cosm Medical is a medical device company building a platform to create Personalized Pelvic Health to improve the lives of women affected by pelvic floor disorder. Pelvic floor disorders, including pelvic organ prolapse, urinary and fecal incontinence, drastically decrease quality of life. These disorders are common (affects 1 in 4 adult women), growing (affects half of all women by 80 years of age) and underserved (stigmatized and traditionally low priority vs other health concerns). The current non-surgical treatment for pelvic organ prolapse is the use of pessaries, which are intravaginal inserts that come in 100+ different sizes and shapes and are fit by trial and error, resulting in a relatively low success rate.  

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At Cosm, we are developing Gynethotics™, or made-to-measure gynecological prosthetics, to replace pessaries and manage pelvic organ prolapse, incontinence and reduce the risk of preterm birth.   Our goal is to transform the art of pessary fitting into the data science of Gynethotics™ by using data to combine a novel 3D measurement technology with 3D printing. Check out our video and website at: www.cosm.care.   

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Join our mission for Personalizing Pelvic Health! 

 

Description:

 

We are currently seeking a Quality Assurance and Regulatory (QARA) Specialist who will be responsible for the ongoing support and maintenance of the Quality Management System (QMS) by helping establish and maintain Cosm's compliance with company SOPs, ISO standards, National and International Regulations.  This is a temporary position covering maternity leave (potential extension, pending performance), providing an excellent opportunity to gain valuable experience in a fast-paced, entrepreneurial environment.  Reporting to the Head of Clinical, Regulatory and Quality, the QARA Specialist is expected to problem solve and develop solutions to quality and regulatory challenges. The individual must have the ability to work independently with minimal supervision and excellent time management skills with the ability to meet tight deadlines. An attitude of “proposing solutions, not just problems” will serve the ideal candidate well. The candidate must be available to start mid-April.

 

The job will be located at Cosm’s manufacturing Lab at the MaRS Accelerator (101 College St.) in Toronto’s 

world-renowned Healthcare Technology hub alongside support within Cosm Medical as part of the 

Autodesk Residency Program within the same ecosystem. 

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Responsibilities:

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• Support the development and maintenance of quality management system (QMS) procedures and documentation to demonstrate compliance to applicable standards and regulations such as ISO 13485, ISO 14971, 21 CFR, and SOR 98-282.  

• Provide company wide trainings and maintain records of training. 

• Conduct data analysis for tracking and trending quality management system performance and identify/implement opportunities for continuous improvement. Investigate, develop, and implement optimizations and improvements to quality processes. Track and manage feedback and complaints from initiation to closure. 

• Participate in corrective and preventive actions to resolve internal and external audit findings and observations (e.g. perform risk assessments, root cause analyses, effectiveness evaluations). Identify non-conformities to oversee the execution of CAPA commitments. 

• Review/verify quality and production records for completeness, accuracy, and adherence to Good Documentation Practices, including supplier records. 

• Provide multi-departmental support related to audits and inspections from regulatory agencies (i.e. MDSAP). 

• Assist in the preparation and submission of regulatory filings for product registrations, including 510(k), CE marking, Health Canada license applications. 

• Assist with execution of Risk Management activities, as required. 

• Collaborate with cross-functional teams to ensure quality and regulatory compliance throughout product lifecycle, from product development to post-market surveillance. 

• Participate in risk management documentation. 

• Perform other Quality Management System-related duties as required. 

• Perform miscellaneous job-related duties as assigned. 

• Adhere to all requirements of the Quality Management System. 

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Knowledge, Skills & Abilities: 

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• Strong understanding of FDA regulations (21 CFR Part 820), Health Canada regulations (CMDR), EU MDR and international standards (ISO 13485; ISO 14971). 

• Excellent English written and oral communication skills, including SOP writing and training experience. 

• Ability to set priorities and work independently with accuracy in a dynamic & fast-paced environment. 

• Demonstrated self-motivation and the ability to take initiative. Strong time management skills and the ability manage multiple competing priorities critical to this position. 

• Excellent attention to detail and ability to keep detailed and accurate records are key components to this position. 

• Individuals who demonstrate commitment to development, finding a better way, and collaboration through teamwork is preferred. 

• Strong computer skills using Microsoft applications (Word, Excel, PowerPoint) is required 

• Strong analytical skills to assess complex issues, interpret regulations and standards, and develop effective compliance strategies and solutions. 

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Education and Qualifications:

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• Bachelor’s degree in a scientific or engineering discipline. 

• Post-secondary education in Quality Assurance or Science-based disciple and/or an acceptable combination of education, training and experience is considered an asset. 

• 2+ years work experience in a QA function in a GMP/GLP or ISO 13485 compliant environment. 

• Knowledge of or experience in medical devices and/or ISO 13485 is required. 

• Completion of Quality Management, Risk Management or related courses is preferable. 

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Physical Requirements and Environmental Conditions:

 

• High-stress and dynamic work environment 

• Light to moderate work with 30 pounds maximum weight to lift and carry 

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This is an opportunity to join our small and skilled team that is leading the way in creating a new personalized medical devices category. 

COSM is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.