Terumo Medical Corporation Sr. Supply Chain QA Engineer in Toronto, Ontario
Sr. Supply Chain QA Engineer
Canada - General Admin
Develop and maintain a quality system for the Terumo Canada site that complies with Terumo Medical Corporation’s quality management system (QMS) and relevant regulatory requirements for the distribution of medical devices.
Ensures that the quality management system requirements are effectively established and effectively maintained in accordance with the requirements of Health Canada, Terumo Medical QMS and other applicable laws and regulations for the distribution center (DC).
Responsible for reporting on the performance of the DC quality system to management with executive responsibility for review.
Develop quality goals and objectives from the Quality Policy that are linked to the business plan. Communicate and implements the Quality Policy.
Oversee the management oversight, NC/CAPA, validation, change control, risk management, internal/supplier audits, calibration, document control/records management, and training systems.
Manage/control quality of product from receiving to distributing ensuring appropriate product conditions and traceability. Ensure nonconforming product is adequately segregated and appropriately controlled until dispositioned.
Communicate the importance of meeting customer requirements as well as regulatory requirements.
Sponsor and/or lead quality improvement activities.
Manages the Internal and External Audit Programs. Liaison with internal and external contacts with regards to quality issues.
Interact with Health Canada relative to medical device reporting, establishment licensing, special access requests, and other regulatory related communications.
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Knowledge, Skills and Abilities (KSAs)
Quality and business process knowledge:
Familiarity with Health Canada Quality Systems requirements.
Ability to identify and recognize how the quality management system potentially affects the wider business of the company
Ability to apply a practical level of statistics. Ability to develop and maintain spreadsheets, pivot tables, metrics, statistical applications, charts/graphs and user-friendly reports
Ability to use process development tools (ex. Lean Six Sigma)
Demonstrated ability to communicate and interact with all levels of the organization including management
Strong interpersonal skills to provide coaching, training, and direction
Individual skills require:
Strong proofreading and writing skills, as well as exemplary attention to detail, organizational and prioritization skills
Demonstrated ability in decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.
Ability to work independently while handling multiple tasks
Strong computer knowledge (MS Office), technical writing skills and proofreading ability
Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.
Position requires a 4-year technical degree in engineering or a scientific discipline
4 - 6 years’ experience in a medical device/pharmaceutical environment,
Experience in quality and regulatory, ideally in a distribution center environment.
Affirmative Action/Equal Employment Opportunity Statement
It is the Company's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. In compliance with the Americans with Disabilities Act (ADA), if you have a disability and would like to request an accommodation with regard to the application and selection processes (for example, the online application process or interviews) or have any questions about our website accessibility, please call 732-302-4902 or e-mail us at Staffing@Terumomedical.com.