Works with project teams to ensure overall software quality is monitored and maintained and / or validates system QA standards necessary to execute test plans and procedures for acceptance testing of new or modified applications / systems.
The Sr. Quality Engineer is responsible for establishing a continuous inspection, testing, analysis and problem resolution process to ensure quality standards can be met on a continuous basis in a fast-paced manufacturing environment General duties will include: evaluation of quality team; implementing quality programs for customers; review extremal complaints; direct vendor quality program; other duties involving quality programs and functions.
Maintains system for monitoring regulatory requirements and trends, including QA related issues within the industry; responsible for maintaining ISO quality system certification and management of all outside audits.
Participate in the deviation process to assure product quality is not adversely affected. Participate in design reviews; acts as an integral member of the supplier performance improvement team along with the Materials Manager.
Work with engineers for the implementation of quality programs, including improvement, standards, inspections, testing, warranty analysis, compliance, complaints, TS 16949 activities, gage control system, and oversee operations.
Manage clinical activities, including patient assessments, care plan development, service level determination, on-site field visits, and the implementation/coordination/maintenance/evaluation of care plans.
Develop and improve quality and business processes with a special focus on product packing, kitting, shipping and transportation practices deployed in company manufacturing sites and Distribution Centers.
Responsible for establishing a continuous inspection, testing, analysis and problem resolution process to ensure quality standards can be met on a continuous basis in a large organization. Develop and lead the implementation of the quality assurance philosophy and strategies. Brings forward and develops quality improvement projects that results in cost and overall efficiency improvements.