Senior Supplier Quality Engineer
Medtronic
Total years of experience :16 years, 5 Months
→ Represent the organization as the primary supplier technical contact
→ Ensures that suppliers deliver quality parts, materials, and services.
→ Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related
problems as they occur.
→ Review and approve changes to Medtronic specifications for purchased materials used in production and manage the
suppliers change execution process with the supplier in partnership other functions
→ Work with pre-market quality engineer to develop and deliver the Product Acceptance Sampling Strategy, Approved
Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
→ Develop technical solutions to complex problems using the corrective/preventative action process; Lead cross-functional
teams to drive root cause and final resolution of supplier related issues
→ Responsible for CAPAs associated with supplier issues
→ Analyze and identify trends from quality data and develop proactive measures with suppliers in support of continuous
improvement
→ Work with Tier 1 Suppliers to ensure adequate controls exist on sub-tier suppliers and that appropriate monitoring is
established by the Tier 1 suppliers
→ Maintain Medtronic supplier audit schedule and lead or participate in the audit/assessment of current or future suppliers,
ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements
→ Develop strong partnering relationships with Supply Chain, R&D, Design Quality Assurance, and Manufacturing.
→ Provide day to day direction to the QC inspection team to assure effective utilization of resources and completion of inspection and test activities
→ inspection methods and procedures as necessary to assure product quality is monitored.
→ Assist in defining and implementing critical attributes and characteristics to be measured for material, components, and products.
→ Initiate and manage non-conforming material records (NCMRs).
→ improvements and implement changes in inspection fixtures and tooling
→ Oversee review of Device History Records (DHRs).
→ Oversee and perform Receiving, In-process and final inspection of products and product sub-assemblies or component.
→ Implement and manage complaint management system including project management documentation, decision coordination and oversight of investigation and closure process.
→ Support the process development teams in all aspects of the Design Control requirements for process development deliverables.
→ Participate in the execution of the Quality Management Reviews regarding all process controls.
→ Develop and manage systemic corrective and preventive action procedures, NCMs and service requests.
→ Responsible for finished goods inspection and lot release; certificates of conformance approvals.
→ Develop and implement inspection methods, sample plans and quality assurance documentation for all receiving and disposition of manufacturing parts, finished goods and returned materials.
→ Develop and maintain overall risk management plans and reports as required under ISO 14971.
→ Develop and coordinate diverse activities aimed
at obtaining and maintaining GMP & ISO compliance.
→ In process checks of biologic mesh products.
→ Initiate, track and support document change requests.
→ Quality testing and sanitation of deionized water system.
→ Test finished product for residual DNA and process chemical levels.
→ Investigation and root cause analysis of product and component non-conformances.
→ Execution of test protocols.
→ Develop inspection procedures and first article requirements for all components as well as communicate quality
issues to suppliers and create CAPA reports as needed and follow up for actions.
→ Follow and adhere to all required protocols and procedures of the certification bodies, scheme standards, and
accreditation bodies.
→ Generate, review and approve quality system documents including standard operating procedures, change orders
and non-conformance and dispositioning related documentations and conduct internal audits.
→ Design and execute best-in-class operational processes and improvement initiatives of moderate complexity for
the quality assurance and improvement program.
→ Perform facility audits to ensure departmental compliance with the regulations; oversee and assist with audits to
assure departmental consistency.
→ Performed numerous quality and regulatory responsibilities in an organization with a diversity of regulated
products including medical devices, cosmetics, pharmaceutical supplies, and children's products.
→ Generated project plans with achievements, project schedules, and project status in the development of quality
system attributes.
→ Served as required member of the Risk/Hazard Analysis Team as well as performed product validations of design
changes and new product designs.
→ Coordinated and maintained records of supplier audits; conducted internal quality system audits for compliance to
FDA QSR's and ISO 9001.
→ Documented and investigated customer complaints/returns, product nonconformities and determine disposition
and corrective and preventive actions.
→ Conducted training of quality inspectors to ensure inspection competencies; wrote components’ specifications and
developed inspection plans, functional tests and maintained inspection database.
→ Performed first article inspection and end of the line audit for blood/fluid warming system, irrigation fluid warming
system and patient adjustable warming system.
→ Inspected and approved in-process specifications, conducted visual and measurement tests, communicated
required adjustments to production supervisor.
→ Provided guidance and expert advice to management on technical, systems, or process-related topics.
→ Conducted and reported internal audits and evaluations; implemented and improved quality control operating
procedures.
→ Assisted in the development of goals and objectives, policies, procedures and protocols as they related to the
performance improvement.
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