• Review of Preproduction and First Article submissions from the Hollister plants and suppliers for new products and significant changes to existing products or processes.• Review design control documents for accuracy, robustments and compliance to regulations• Mentor and train others on subject matters related to principles and practices of Quality Engineering• Guide cross-functional teams in the appropriate application of design controls in compliance with global regulatory requirements for medical devices. Facilitate project quality activities addressing design and process verification / validation for new products and significant changes to existing products or processes.• Facilitate design FMEA, participate in process FMEA, and conduct risk assessments in compliance with ISO 14971.• Interface with Hollister plant and supplier Quality Engineering and Quality Assurance for new products and significant changes to existing products or processes.

Quality Engineer representative for new product development. Responsible for review and approval of all design control activities as well as test method development and validation• Participates in development and approves design input/output documents.• Participates in the development and approves risk management documents.• Responsible for development of incoming inspection test methods and associated fixtures.• Responsible for overseeing incoming inspection over all components used in new product development.• Participates in design verification/validation strategy development and reviews/approves all design verification and validation documents.• Participates in process validation strategy development and reviews/approves all process validation documents. • Interfaces with vendors to ensure all components meet specifications.

-Conducts PIR(Product Inquiry Reports) and FIR(Failure Inquiry reports) to determine root cause and make manufacturing/quality improvements.-Authors and approves Validaiton protocols(IQ/OQ/PQ)-Validates Production test methods(TMV). -Implements process/system improvements throughout the Incoming and production processes.-Design check fixtures and determines gauging requirements for incoming parts. -Supports calibration, including conducting out of tolerance investigations for equipment, review and remediation of calibration procedures. -Risk management.-CAPA-Issues and approves SCARs as necessary when failures occur at incoming inspection.-Creates, approves and dispositions NCMR(Non-conformance material reports) from rejections at incoming inspection.-Supports FDA audit activities.-Design Control remediation(design input/output identification, remediation of validations, FMEAs, re-execution of Design Verification, Design Validation)

-Conducts PIR(Product Inquiry Reports) and FIR(Failure Inquiry reports) to determine root cause and make manufacturing/quality improvements.-Authors and approves Validaiton protocols(IQ/OQ/PQ)-Validates Production test methods(TMV). -Implements process/system improvements throughout the Incoming and production processes.-Design check fixtures and determines gauging requirements for incoming parts. -Conducts Out of Tolerance Investigations to determine potential risks of out of tolerance gauging.-Risk management.-CAPA-Issues and approves SCARs as necessary when failures occur at incoming inspection.-Creates, approves and dispositions NCMR(Non-conformance material reports) from rejections at incoming inspection.-Supports FDA audit activities.-Design Control remediation(design input/output identification, remediation of validations, FMEAs, re-execution of Design Verification, Design Validation)

-Manages the Quality portion of the ECO process.-Responsible for qualifying new products for production and ensuring the processes are in place to produce products that meet quality requirements consisentely.-Troubleshoots field returns, and manufacturing issues to detrmine root causes and provide solutions.-Implements Six Sigma to the production and new product development process.-Conducts audits to ISO 9001 and ISO 13485.-Participates in risk management and ISO 14791 activities.

-Responsible for writing programs for the Automated Optical Inspection process that will catch all defects on circuit boards while minimizing false errors that decrease the throughput of the process.-Responsible for managing the feeder repair process, including ordering parts, and ensuring feeders are repaired consistently and are available for production.

• Works as a contractor for Kelly Services.• Performs specified experimental tasks related to testing of compression sleeves.• Interacts with vendors and external contract groups to set, monitor and accomplish specific tasks.• Designs manifold and electronics package assembly for pneumatic valves and electronic components to satisfy space and port requirements using SolidWorks.