Monitor, Measure & Report on Quality Issues; support Customer, In-House & Third-Party Audits (Inspections Root Cause Corrective Actions); assist the Quality Manager through Internal & External Change Control Procedures.
Provides quality engineering support and consultation for design and development of contact lenses Perform quality and regulatory design control and manufacturing process impact assessments for all change packages as a Global Change Control Board R&D representative.
Under moderate supervision, verifies that software changes submitted by developers function as documented and without errors. Participate on quality projects and processes within department/team. Documents issues found during testing and follows through to resolution.
Develop Validation Master Plans and Validation Project Plans to ensure that all validation tasks required for supporting operational areas and corporate projects are identified and completed within established time frames.
Analyze requirements and identify strategies that maximize test coverage and/or improve system reliability and performance; prepare detail test plan and consult with Business Analysts on testing options and strategies.
As a Supplier Quality Engineer, you will support product manufacturing and process optimization assignments throughout the Supply Chain, Quality Assurance, Manufacturing, Inspection and Test Processes.
Provide QA support for process capability studies conducted on production lines in support of PPAP and improvement activities; establish measurement method standards for process checks and PPAP layout per ASME best practices measurement methods.
Completes Qualification of materials and components (including spare parts), development/ improvement of supplier processes for CtQ's, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met.