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.
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.
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.
Lead internal audits, coordinate third-party audits, resolve customer complaints, lead continuous improvement projects, manage the calibration system, help establish product specs and support Production through SPC and advanced statistical analysis.
Supervises staff to include hiring, training, evaluating performance, providing compensation recommendations, and determining disciplinary actions when necessary; those employees over quality assurance may not directly supervise employees.
Develop and continually update the production schedule on a weekly, monthly and quarterly basis and ensure alignment/adjustment of manufacturing schedule to meet development program milestones and corporate goals, as appropriate.
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.