Supplier Quality Engineer

The Supplier Quality Engineer executes the Quality Engineering function for the plant.Participates in the planning, execution and implementation activities for components for medical disposable products and is a key member of the Quality Assurance Technical team.Is also responsible for the supplier compliance programs.Leads and monitors advanced quality planning and is an instrumental part in the approval process for existing and potential suppliers.- Improves products through the implementation of quality management policies, procedures, specifications, test methods and measurement systems.- Develops new and/or improved processes and techniques for engineering tasks.- Works with Corporate Product Quality Engineering to develop risk management plans and reports utilizing risk management tools such as FMEAs.- Is responsible for the review and approval of drawings, calculations and specifications.- Is responsible for the review and approval of supplier validation protocols and reports required for the development and qualification of process e.i. IQ/OQ/PQ process.- Coordinates and executes the component part approval process.- Interacts with suppliers and internal resources.- Applies systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving supplier quality issues.- Provides supplier trending analysis on quality issues and performance metrics.- Develops and updates Quality Plans.- Coordinates and participates in elements of investigations regarding customer complaints.- Minimizes customer complaints due to product quality through effective corrective action and preventive actions.- Ensures compliance of project activities to appropriate regulations and standards (FDA, ISO, EN).- Is responsible for the maintenance of Approved Supplier List (ASL).- Coordinates and conducts quality evaluation for new and existing suppliers, assigns supplier category to new sourcing requests and in conjunction with the areas of Sourcing and Engineering, qualifies a new supplier.- Performs vendor audits and qualifications.- Approves and monitors supplier improvement plans.- Is responsible for administration and implementation of all activities in regards to supplier performance (PPM/DPPM/NCR) metrics/scorecards.- Coordinates disqualifications and maintains the complete ASL- Coordinates with the Sourcing and Legal areas the establishment of minimum quality requirements if there is a deviation from the standard Quality Agreement.- Performs product and process evaluations to identify areas for improvement.- Implements approved changes using Quality Engineering principles and fully documents requirements on a timely basis.- Works closely with R&D, Engineering and Manufacturing Operations to identify and resolve production and quality system deficiencies.- Runs material trials and develops appropriate testing to compare results.- Assists in regulatory reporting activities.- Provides direction for the implementation of incoming Inspection Plans, First Article Inspection, In-Process and Final Product Inspection, Sampling Plans, inspection and test acceptance criteria, Capability Studies, GR&R Studies and resolves non conformances.- Coordinates supplier deviation/supplier corrective action request (SCAR) process.- Uses quality tools and practices to establish approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies.- Supports the validation of product designs, manufacturing processes, equipment, and procedures required for the production and delivery of finished product.- Initiates and directs corrective actions to problems related to product or process quality.- Communicates essential Management Review data to senior leadership such as supplier performance trending and analysis.- Performs other related duties as assigned.When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win.As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful **Danaher Business System** tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you've ever wondered what's within you, there's no better time to find out.