.Performs tasks such as, but not limited to, the following:- Leads development, implementation, maintenance and improvement of system(s) and processes that ensure the correct documentation/information/instructions are available for use and that changes are implemented in a timely manner.
Works closely with users of these system(s) and processes to better understand their needs and drive improvement to enable users to be more effective and efficient at their functions.
Ensures that system(s) and processes meet industry standards (e.G., ISO) and customer requirements while driving toward "world class" practices and standards.
System(s) and processes may include, but are not limited to, the following:- Standardizes internal documentation/information format and hierarchy- Ensures that proper revision of internal documentation/information is accessible and utilized- Ensures authorization of change commensurate with magnitude/impact of change- Ensures timely, accurate implementation of changes (initiated both externally and internally)- Archives documents/information to maintain history/traceability- May also be responsible for quality benchmarking and testing, working to identify areas for improvement, developing/modifying programs that measure the quality of product, processes, and services and drive corrective actions/quality improvement efforts.
Develops quality metrics and goals to drive quality improvement efforts.
Distributes reports that track defects as product is assembled and tested through the plant and defect information about products that have failed at a customer site.
**Knowledge/Skills/Competencies**:- Strong knowledge in medical devices industry of "state-of-the-art" documentation and quality systems.- In-depth knowledge of quality metrics, ISO13485 standards, and processes.- Knowledge of software and its uses in generating reports, capturing data, and presenting data in an understandable format.- Strong knowledge of manufacturing processes.- Strong project management skills.- Knowledge and understanding of the business unit and how decisions impact customer satisfaction, product quality, supplier quality, on-time delivery and the profitability of the unit.- Ability to coordinate a wide variety of resources to meet production quality and quantity metrics, including supplier quality.- Ability to effectively communicate with a wide variety of internal and external customers.- Ability to effectively lead, train and motivate a diverse group of employees to achieve high production levels within tight time deadlines and in a highly dynamic manufacturing environment.Celestica is an equal opportunity employer.
All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law)