|Job Category||Trades & Technical|
|Application Deadline||March 31, 2020|
|Experience Required||2 years|
|Job Duration||1 year|
As a member of the Facilities Department, you will play in a key role overseeing quality adherence pertaining to Building, Facilities & Utilities Systems in a medical device manufacturing environment.
You will be considered the subject matter expert and use your knowledge to understand existing processes and implement continuous improvement initiatives.
ESSENTIAL DUTIES AND RESPONSIBILITIESResponsible for implementing and maintaining effectiveness of Quality System in Facilities.Coordinate CAPA (corrective action, preventive action) system activities in a timely manner including effectiveness checks; these tasks include:Generate (where required) and manage CAPA documents (ERs, PCs, CAs, PAs, Investigations).Investigations into non-conformances (NCRs) and documentation of findings and Corrective Actions in Quality Reports (QRs).Be the Initiator, Evaluator, Resolution Planner, Investigator to complete CAPA documentsComplete Design Change, Validation, Verification and Document Change processes and approvals.Identify and evaluate ways to improve the organization (cost reductions, use of resources, policies/procedures, products); generating useful new ideas, approaches or techniques.Develop change control packages to ensure facilities remain in qualified, validated state, including definition of appropriate requirements in change control documents, and tracking to completion the identified actions.And other duties as required.
EXPERIENCETypically requires 2+ years of related experience (such as Quality, Compliance, Engineering) within a regulated environment.Experience with various quality system processesExperience in the Medical device, diagnostics or pharmaceutical industries is preferred.Previous experience with regulatory agencies is preferred.Bachelors Degree in STEM, or equivalent;Knowledge of ISO 13485; Knowledge of quality management techniques and the application and principles of quality engineering, strong knowledge and application of concepts, practices and procedures.Ability to collaborate effectively with multidisciplinary team members and also to work independently;Experience in the development, validation, or quality review of high volume automation is an asset.Experience with statistical software an asset.
If you are interested in this role, please contact
Only those who are qualified for the role will be contacted