Theodore Schmidt Email & Phone Number

Planned and conducted IQ, OQ and PQ activities for manufacturing processes and equipment including hand tools and fixtures, environmental storage chambers, and process work stations. Also Manufacturing Engineer accountable for silicone transfer molding process• Planned and conducted Test Method Validations for manufacturing processes for visual attribute and measurement process inspections• Generated specifications and manufacturing work instructions and procedures• Assessed impact on products delivered when measuring instruments were found out of tolerance• Assessed impact of nonconformances as a member of material review board• Led responses to regulatory body findings and devised required corrections• Participated on Risk Management analysis and change activities in response to field and manufacturing events• Participated in change control collaborations and approvals as the change board manufacturing representative• Defective product disposition in production• Defective product disposition in Receiving Inspection• Participated in Process Failure Modes and Effects Analysis generation and updating in response to field and manufacturing events• Assessed impact on products delivered when measuring instruments were found out of tolerance• Generation, maintenance and updating of Assembly Procedures• Provided support to Change Control Board as Product Support Engineering representative• Teamed with Quality Engineering to generate Master Validation Plan and Report• Responded to questions resulting from review for CE marking renewal from GMEDo Final cleaning Catheter o Final Cleaning for Implantable Insulin Pumpo Titanium machined part Passivation Process Validation• Performed or supported IQ, OQ and PQ tests• Performed or supported Test Method Validations• Manufacturing Engineer support for the catheter production line

Valencia, Ca, Us

Generated and maintained SOPs for Control of Suppliers, CAPA System, Environmental Monitoring, Material Purge Process, Contaminated Material Handling and Supplier Corrective Action• Performed onsite audits for Control and Approval of suppliers and Supplier Corrective Actions• Supported production for products to enable patients to regain mobility or grasping ability. Supported MRB activities from material receipt through final shipment• Supported transition of manufacturing from Valencia to contract manufacturer in US and Mexico• Helped implement repair center for return products within facility to support field retuned products• Updated EO Sterilization procedure to reflect true process and handled annual cycle verification activities and revalidation

Initiated development of Quality System elements and procedures based on ISO13485 and 21 CFR Part 820 that included, Receiving Inspection, Material Review, Corrective Action, Risk Management, Device History Record, Clean room monitoring and acceptance, Employee Training, Supplier Surveillance, Sterilization lot release, and Pyrogen sampling and lot acceptance.• Established the Receiving Inspection function including the procurement of automated inspection tools, used a cross function team to base decision on mechanical inspection and measurements requirements• Determined leak test specification for the implanted device through the use of a leak rate model that produces conditions that will result in failure based on the mechanical design and configuration.• Generated Mechanical Failure Modes and Effects Analysis for the IDP and accessories and coordinated the completion of the Electronic FMEA and reported findings in the Risk Management report based on EN 1441• Developed a failure reporting process that resulted in the ability to provide trend analysis information that enabled allocation of resources for problem resolution and prevention.• Monitored clean room performance for both viable and non-viable particulates and surface contamination in the work environments and coordinated periodic revalidation