RYAN S. LENARCIC

Company Overview: Oxus is an engineering, manufacturing, and service company specializing in medical devices and gas separation technology. We design and manufacture our products in Auburn Hills, Michigan. As an ISO 13485 certified, MDSAP, and FDA registered OEM supplier, we understand the technical challenges of product realization. We have supported our customers in bringing to the market an assortment of challenging products; from industrial design and engineering, through process design and manufacturing.

• Lead Quality and Regulatory personnel for a Class II medical device manufacturer including Class II Medical Devices Zen-O Portable Oxygen Concentrator, Zen-O Lite Portable Oxygen Concentrator, Oxus RS-00400 Portable Oxygen Concentrator, and Oxus Sieve Beds.
• Ensure all departments maintain requirements starting with product design and development through post-market surveillance.
• Assist with the development of Device Design, Software Life Cycle, Risk Management and Regulatory planning (ISO 14971, 10993, 18562, IEC 62304, etc.), Manufacturing Readiness, and development/approval of Device History Records (DMR, DHF, DHR).
• Monitor and measure quality targets to ensure customer satisfaction and Cost of Quality metrics.
• Successfully prepared 510(k) submission for Class II Oxygen Concentrator, K162433.
• Supported the successful 510(k) development and submission for Class II Sieve Beds, K211056.
• This is the first known 510(k) for a component part.
• Led three FDA inspections with no major findings.
• Achieved MDSAP certification containing US FDA, Health Canada, and Brazil ANVISA qualifications.
• Successfully prepared and achieved eight (8) Class II Medical Licenses for Health Canada.
• Maintain CE Marking (MDD 93_42EEC). Certified to EU MDR 2017/745 implementation and auditing. PRRC.
• Maintain ISO 13485 certification for the organization.
• Responsible for all FDA reporting and database maintenance (FURLS, Facility Registration, Device Listings, UDI/GS1, eMDR, MAUDE, Unified Submission Portal, Small Business Determination, Non-Repudiation Letters, etc.)
• Implemented an economical eQMS documentation system in compliance with § 21 CFR Part 11, ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
• Oxus is an engineering, manufacturing, and service company specializing in medical devices and gas separation technology. We design and manufacture our products in Auburn Hills, Michigan. As an ISO 13485 certified, MDSAP, and FDA registered OEM supplier, we understand the technical challenges of product realization. We have supported our customers in bringing to the market an assortment of challenging products; from industrial design and engineering, through process design and manufacturing.

Company Overview: Supplier of components to the Military, Automotive, Alternative Energy, Commercial, and Aerospace markets. Processes include cutting, forming, welding, bonding, and painting. Primary customers include Navistar, Vestas, GDLS, Siemens, Spirit Aerosystems, Raytheon, Oshkosh, CAT, Meritor, Alcoa, AM General, BAE, Mitsubishi, Manitowoc, EMD, GM, Ford, and Volvo.

• Led Quality Department personnel within six facilities local to the Lapeer area.
• Responsible for Weld Engineering and Quality Assurance groups.
• Trained the organization and implemented multiple Quality tools and methodologies including APQP, Quality Gates, Root Cause Analysis, Corrective Action, Error Proofing, Supplier Development / Qualification, PPAP, and SPC.
• Ensured compliance to all customer and government requirements while developing the organization into a Quality and process leader.
• Developed and trained organization on full APQP process to ensure successful product launches.
• Procured removal from all customer Quality hold provisions with successful sustainment.
• Achieved and maintained ISO 9001 and AS 9100 certifications.
• Successfully developed Metric system to drive continuous improvement.
• Supplier of components to the Military, Automotive, Alternative Energy, Commercial, and Aerospace markets. Processes include cutting, forming, welding, bonding, and painting. Primary customers include Navistar, Vestas, GDLS, Siemens, Spirit Aerosystems, Raytheon, Oshkosh, CAT, Meritor, Alcoa, AM General, BAE, Mitsubishi, Manitowoc, EMD, GM, Ford, and Volvo.

Company Overview: Principle supplier of armor components and assemblies for the MRAP and M-ATV military programs also servicing the heavy truck, agricultural, construction, school bus, and automotive markets. Processes include stamping, welding, punch press, laser, paint, machining, press brake, cold bonding and assembly with the latest technology.

• Led 45 Quality Department personnel within three facilities: Memphis, TN; Conway, AR; and New Boston, OH.
• Ensured the voice of the customer while driving multiple improvements within the organization to improve efficiency along with gaining profitability.
• Implemented multiple Quality tools and methodologies including Statistical Engineering, APQP, Root Cause Analysis, Corrective Action, Error Proofing, Value Stream Mapping, PPAP, and SPC.
• Ensuring compliance with all customer and government requirements while leading the organization into a world class quality system.
• Implemented full traceability system to meet and exceed customer TACOM requirements.
• Successfully removed all customer imposed third party product verification requirements and instilled confidence in the Quality System.
• Developed Metric system to drive continuous improvement.
• Principle supplier of armor components and assemblies for the MRAP and M-ATV military programs also servicing the heavy truck, agricultural, construction, school bus, and automotive markets. Processes include stamping, welding, punch press, laser, paint, machining, press brake, cold bonding and assembly with the latest technology.

Company Overview: A leader in full-service precision metal stamping and fabrication for the heavy truck, agricultural, construction, military, medical, school bus, and automotive markets. Processes include heavy stamping, welding, punch press, laser, paint, press brake, and assembly.

• Supervised 33 professional and administrative staff in developing and implementing a highly successful total quality management program.
• Trained the organization and implemented multiple lean-manufacturing tools and techniques, including 5s, Kaizen, One Piece Flow, Value Stream Mapping, Constraints Management, TPS, Visual Plant Management, Just-in-Time processing, statistical process control (SPC) and design of experiment (DOE).
• Developed and implemented an APQP system, including all facets of the organization, which proactively increased customer satisfaction and customer loyalty while reducing quality concerns.
• The system included Design Error-Proofing, Design for Manufacturing, Design for Assembly, and Design for Six Sigma methodologies.
• Reduced defects detected (PPMs) both before and after delivery by 87%.
• Increased On-Time Delivery to 98% while increasing the production parts approval process (PPAP) 1st pass yield and On-Time Submission to 100%.
• Led the team that banked cost savings in excess of 4% of the company's gross sales dollars through product and process improvements during 2005 through 2008, allowing the organization to absorb customer price concessions.
• A leader in full-service precision metal stamping and fabrication for the heavy truck, agricultural, construction, military, medical, school bus, and automotive markets. Processes include heavy stamping, welding, punch press, laser, paint, press brake, and assembly.

Company Overview: A manufacturer of highly designed roof, body, and other systems for the automotive industry. One major project was the joint GM/ASC Chevrolet SSR Roadster.

• Developed and implemented a total quality management program, performing multiple Six Sigma and Red X (Shainin) projects that dramatically reduced or eliminated scrap, constraints, and defective parts.
• Utilized lean-manufacturing methodologies such as Standardized Work, One Piece Flow, DOE, Toyota Production System (TPS), lean manufacturing, SPC, PPAP, 5s, and Kaizen.
• Interfaced continuously with customer representatives, internal executives, and labor personnel to create a work environment dependent on quality.
• Managed the team that reduced defects per million and overall customer complaints to world-class levels.
• Developed and implemented effective supplier accountability and monitoring systems.
• A manufacturer of highly designed roof, body, and other systems for the automotive industry. One major project was the joint GM/ASC Chevrolet SSR Roadster.

Company Overview: A major manufacturer of automobiles and trucks.

• Member of quality assurance team that successfully launched multiple vehicle product lines.
• Developed and implemented a process to predict J.D. Power scores for new vehicle launches.
• Developed suppliers in the steel and metal forming arena to create a world class supply base.
• Earned Red X Journeyman credentials with Supplier Quality Group.
• A major manufacturer of automobiles and trucks.

Company Overview: NSS manufactures a variety of fasteners and mining bits through cold forming operations.

• Led initiatives to reduce scrap, customer complaints, and internal and external defects.
• Successfully introduced advanced metrology systems and recommended and implemented lean-manufacturing methods.
• Successfully reduced constraints and improved efficiency.
• NSS manufactures a variety of fasteners and mining bits through cold forming operations.

Company Overview: Autoport supplied multiple GM assembly plants with outside rearview mirrors.

• Ensured total quality of products entering and leaving the facility.
• Identified bottlenecks and eliminated constraints, which improved operations and increased productivity.
• Autoport supplied multiple GM assembly plants with outside rearview mirrors.