Dyron O'Farrell
Quality Control - Operations Management
Fort Wayne,United States
Summary
Management experience including direct reports, budgeting, staffing, and training. Medical device production background with training in FDA, ISO, and OSHA regulations, extensive quality inspection and inspection equipment, knowledge of machining, laser etching, finishing, passivation, assembly, packaging, logistics, engineering and document control. Goal oriented and operational leadership minded with experience in Lean Six Sigma. 10+ years experience in sales with achieving set goals and on time delivery.
Overview
14
14
years of professional experience
4
4
years of post-secondary education
Work History
Senior Quality Engineer
Avalign
Fort Wayne, Indiana
07.2022 - Current
- Lead liaison for a tier 1 customer while also supporting 9 other tier 2-5 customers
- Create control plans, inspection plans, and process sheets for production
- Supported quality team members during corrective action updates
- Expanded risk management measures through spot-checking and increased randomization of inspections
- Developed training protocols in alignment with company quality standards and ISO 13485 9001 regulations
- Participated in multi-disciplinary defect reviews to discern and address root causes
- Built strong rapport with team members, management and clients to facilitate efficiency and productivity
- Partnered with senior management to analyze issues and find appropriate solutions
- Demonstrated product and quality expertise in product inspections.
- Led problem-solving activities to quickly identify and permanently resolve quality and productivity issues
- Facilitated process improvements to successfully decrease errors
- Performed quality inspections and drafted reports to detail non-conforming material issues
- Developed traceability documentation to aid in investigating faults and defects
- Contributed to root cause analysis to determine core reason for failures and errors
- Executed operational audits and assessed company operations, compliance and other associated risks
- Reported on non-compliance issues and other negative factors discovered during production
- Maintained compliance with industry standards and regulatory compliance during managed projects
- Coordinated with quality control staff to complete inspections
Quality Manager
L.H. Medical
Fort Wayne, Indiana
11.2018 - 07.2022
- Continuous Improvement Programs that optimize performance, quality of products and reduce costs.
- Maintain department equipment performance by establishing and developing quality standards, operations, certifying instruments and troubleshooting procedures. Arrange equipment replacement, preventative maintenance, repairs, prepare justification for new lab equipment, prepare purchase orders, and arrange installation and qualification.
- Maintain department supplies by monitoring inventory levels, forecasting supply needs, placing and expediting orders, and verifying receipt of supplies.
- Maintain department productivity by monitoring and tracking workload volumes moving through other departments. Identifies peak periods and downtime in order to make operational or staffing adjustments.
- Writes user manuals to standardize inspection methods and oversees the training of employees.
- Manage department staff by recruiting, selecting, orienting, and training employees. Instructs staff through coaching, counseling, and discipline. Completes staff planning, monitoring, and evaluations in accordance to their job profiles.
- Evaluate and coordinate work order completion by assigning and following up with workloads assigned to department staff.
- Provide support to all departments and personnel by being Quality Manager on call; being available 24/7.
- Ensure compliance and adherence to local, state, and federal regulations; including FDA, ISO, and OSHA.
- Help coordinate and facilitate Quality needs, documentation, validation, and staff for projects.
- Responsible for identifying, investigating, and reputing Quality Control events including process deviations, out of specifications, and out of trends.
- Experience with Lean Six Sigma, medical terminology, implantation knowledge and Microsoft Suite
- Extensive background in layout inspection using a wide range of equipment including micrometer, caliper, thread gages, plug gages, indicators, profilometer, Vision System, CMM, etc.
- Working knowledge of machining, laser etching, finishing, passivation, assembly, packaging, logistics, document control and engineering.
Quality Assurance Technician
Titan Metal Worx
Fort Wayne, Indiana
12.2017 - 11.2018
- FARO Arm, optical comparator, micrometer, caliper, feeler gage, gage block, pin gage, thread gage, go/no-go gages, profile gage, bore gage, fillet gage, height stand, dial indicator, tape measure, scale, blueprint reading
- Calibrate and record inspection equipment
- Containment, corrective action, process improvement
- First piece inspection and final inspection for laser, plasma, saw, lathe, mill, and fabricated parts
- Audits for all departments
- Writing work instructions for inspection and job processes
- Building routers for new parts and revision changes, production part approval process (PPAP)
- Shipping and Receiving, invoice tracking, labeling, fork lift
- Record logging, copier, email, Microsoft Suite
- Ensure manufacturing lead time
- Employee training
- Company quality policy and ISO
Box and Label: Poly/Sports Medicine/Trauma/Metals
Zimmer Biomet
Warsaw, Indiana
02.2017 - 12.2017
- AS/400, Plotview, Microsoft Suite
- Label printing, wanding/VEI
- Packaging in Poly, Sports Medicine, Trauma and Medals
- Clean room (Certified)
- Packaging testing and inspection
- Value stream, Gemba Board
- Employee training
- Company quality policy, 5S and FDA
Additive Manufacturing Operator
Zimmer Biomet
Warsaw, Indiana
02.2015 - 12.2017
- Micrometer, caliper, thread gage, go/no-go gage, coordinate measuring machine (CMM), optical comparator, Keyence inspection, white light and blue light inspection systems, height stand, blueprint reading, geometric dimension and tolerancing (GD&T)
- J.D. Edwards Inventory and Reporting, Mini Tab, Trapezium, Geomagic Design X, Microsoft Suite, email
- SLS 3D centering printer (Certified), nylon powder mixology for SLS 3d centering printer, glass bead blast, mass finish tumbler, Meile washer, manufacturing assembly, packaging, label creation, label printing, fork lift
- Communicate with doctors and sales representatives to ensure a 24 hour lead time for surgery dates, Gemba Board
- Cadaver labs
- Company quality policy, 5S, and FDA
Waiter, Bartender, Caterer, Host
Club Soda
Fort Wayne, Indiana
03.2010 - 02.2015
Education
Bachelor of Science: Business
Indiana University Purdue University Fort Wayne
Fort Wayne 09.2018 - Current
Skills
Manufacturing
undefinedTimeline
Senior Quality Engineer
Avalign
07.2022 - Current
Quality Manager
L.H. Medical
11.2018 - 07.2022
Bachelor of Science: Business
Indiana University Purdue University Fort Wayne
09.2018 - Current
Quality Assurance Technician
Titan Metal Worx
12.2017 - 11.2018
Box and Label: Poly/Sports Medicine/Trauma/Metals
Zimmer Biomet
02.2017 - 12.2017
Additive Manufacturing Operator
Zimmer Biomet
02.2015 - 12.2017
Waiter, Bartender, Caterer, Host
Club Soda
03.2010 - 02.2015
Similar Profiles
Marisa VelasquezMarisa Velasquez
Quality Engineering Technician at AvalignQuality Engineering Technician at Avalign
James SchweyerJames Schweyer
Swiss Machinist at AvalignSwiss Machinist at Avalign
Mikey RoselleMikey Roselle
Material Handler at AvalignMaterial Handler at Avalign