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Engineer Quality

Location:
Grand Rapids, Michigan, United States
Posted:
August 27, 2018

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Resume:

RONALD F. OKULICZKI JR. 774-***-**** **** Vista Point CT NW Grand Rapids MI 49534 ac6t0s@r.postjobfree.com

EXPERTISE IN:

Domestic and International Standards and Quality Systems:

FDA - GMP/QSR (8020 & 21 CFR 11), ISO (9001 & 13485)

European (CE, EN, and TUV)

IPC 600, 610, 620

Supply Chain Management:

Performance Measurement Systems and Reporting Requirements of Quality, Response, On Time Delivery, Service, Packaging, and Product Identification.

Technical Knowledge And Skills:

PCB, Plastics, Lasers, Optics, Fiber Optics, Electro-Mechanical Assemblies, Cables, Sub-Assemblies, Power Supplies, Motors, Sheet Metal, Software, Molding, & Paint.

Read and Interpret Electrical, Electronic, and Mechanical Blueprints.

Troubleshoot problems to the component level.

Problem Solving:

Holistic Point Of View Solving Problems With Designs, Manufacturability, Inspection Criteria’s, Suppliers, Process, Procedures, Customer Returns, Audits (Internal, Supplier, & Regulatory), Regulatory Issues & Complaints.

World Class Manufacturing:

Good Manufacturing Concepts (GMP) Training

Green Belt, Six Sigma, Lean Manufacturing, Just In Time, Kan Ban, Dock to Stock Programs, Closed Loop Corrective Action Preventive Action (CAPA)

Regulatory License Requirements:

FDA (510k), Canadian Standards Association (CSA), Brazilian, French, Japan, Korean

Workmanship Standards:

US (UL, & NIST), and IPC 600/610, Tools, Techniques, Concepts, and Training:

SPC, TQM, Process Mapping, Pareto, Cause and Effect diagrams, Value Stream Mapping, MTBF, and Inspection Criteria’s and Sampling Plans.

Design Controls:

Research and Development Design Support Programs from Concept, to Shipping (FMEA/FTA, Supplier Selection Assessment, Prototype, Pilot, New Product Introduction (NPI), through Production. Includes verification and validation, SOP creation/markup and documentation revision.

Leadership:

Inspire, Lead, Train, Cross-Functional Teams In All Facets Of Quality Assurance Engineering In The Benefit Of The Organization.

RONALD F. OKULICZKI JR. 774-***-**** 2511 Vista Point CT NW Grand Rapids MI 49534 ac6t0s@r.postjobfree.com

WORK EXPERIENCE

Tier 1 Automotive Supplier, MI 07/2017 - 06/25/2018 SUPPLIER DEVELOPMENT ENGINEER

Responsible for leading the cross functional Advanced Quality Planning Development process for new product development (electrical, electronics and electromechanical commodities).

Ensures that new electronic / electromechanical designs meet established product development, design quality expectations for design intent, manufacturability, quality, delivery and service.

Provide assessments and data based guidance during new product developments on all global projects.

Responsible for technical feasibility design reviews with global supply base of (electrical, electronics and electromechanical commodities).

Provide technical and operational guidance to the design team (global) suppliers while managing the corrective action process for supplier issues.

Verify root cause analysis and ensures the permanent corrective actions address all types of root causes including escape, occurrence and systematic issues (Man, Method, Machine.

Managed Supplier APQP and PPAP per companies PDP process.

Monitored supplier status through SOP +90 days and incorporates lessons learned into supplier development plans.

Executes ongoing Global audits of approved suppliers and potential new suppliers.

CAE Healthcare, Sarasota FL 04/2013 - 07/2017

QUALITY SYSTEMS SPECIALIST ENGINEER

Created and implemented ISO 9001 compliant Quality System.

Managed Quality Engineers and inspectors working in the inspection and testing activities from Receiving Inspection, Functional Verification and Final Inspection of all production products to ensure high productivity and high technical integrity.

Ensures projects are completed on time and within budget.

Advisor to quality assurance engineering team regarding projects, tasks, and operations.

Provided consultation on complex projects and is considered to be the top level contributor/specialist. Relies on extensive experience and judgment to plan and accomplish goals.

Responsible for leading the cross functional Advanced Quality Planning Development process for ALL new product development (electrical, electronics, electromechanical, plastics, fiber optics, mechanical and pneumatic commodities).

Ensures that new electronic / electromechanical designs meet established product development, design quality expectations for design intent, manufacturability, quality, delivery and service.

Performed Supplier Selection, Audits, Reviews and Corrective Actions.

Interact with suppliers to ensure compliance.

Design, implement and document procedures from process control, process improvement, testing and inspection.

Created quality standards and protocols for quality assurance testing models.

Assisted in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment.

Medical Device Quality Consultant MA 01/2008 – 04/2013

QUALITY ASSURANCE ENGINEERING CONSULTANT

Improved customer quality systems in all project aspects from creation of Quality Assurance Engineering Design Controls, New Product Introduction to Customer Complaints and Customer Return Root Cause analysis.

Medical Device Quality Assurance Engineering Contract Support providing expertise to management in the areas of Manufacturing, Purchasing, Design, and Quality System. Created and maintained ISO 13485 compliant quality systems. Direct - Optim, Rhytec

Columbia Technologies, Worcester MA 07/2006 – 10/2007

QUALITY ENGINEER

Medical Device Contract Manufacture

Customer liaison for product transfer to manufacturing.

Identified and resolved problems with designs, manufacturability, inspection criteria’s, suppliers, process, procedures, customer returns, audits and supplier defects (components, PCB, cables, full/sub assemblies, boxes, and plastics).

Segregated defected products keeping production line(s) up and running while initiating corrective and preventive action plans.

Candela Laser Corporation, Wayland MA 2001 - 2006

QA SUPERVISOR / MFG ENGINEER

Medical Device Manufacture of Aesthetic Laser Systems

Created and revised SOP’s to ISO 13485 requirements while staying compliant to GMP/QSR (8020 & 21 CFR 11).

Created value added closed loop quality measurement reporting tools saving the company $$$ (millions).

Maximized product reliability through creation of engineering change orders (improving designs).

Reduced manufacturing scrap.

Improved manufacturing yields & cycle times.

QA Rep. on all company R&D and engineering efforts.

QA/MFG Engineer responsible for the transfer of all engineering products to production.

Revised drawings/procedures, & trained production on new products.

Created Inspection criteria’s and sampling plans.

Created and revised SOP’s to ISO 13485 requirements while staying compliant to GMP/QSR (8020 & 21 CFR 11).

Manage QA staff of eight providing direction & priorities for production, incoming inspection, final test and product release.

Overall responsibility of release of all products.

Created and revised SOP’s to ISO 13485 requirements while staying compliant to GMP/QSR (8020 & 21)

Jabil Circuit, Billerica, MA 2000 – 2001

SUPPLIER QA ENGINEER

Telecomm Contract Manufacture

Responsible for ISO 9002 implementation and training.

Developed Receiving Inspection procedures (methods, criteria’s and sampling plans) and trained inspectors.

Responsible for supplier corrective actions & customer notifications.

Responsible for the identification and resolution of manufacturing related supplier defects (component, PCB, cables, boxes, and plastic). Segregated defected products keeping production line(s) up and running.

Created AVL criteria, implementation & compliance.

Future Electronics, Bolton, MA 1996 - 2000

QUALITY SYSTEMS ENGINEER

Electronics Distributor

Developed National Product Identification Requirements accepted by all component manufactures.

Created Corporate Supplier Quality Delivery Reporting Measurement System.

Presented Quality System to customers & suppliers.

Summit Technology, Wayland, MA 1992 - 1996

QUALITY ENGINEER

Medical Device Manufacture

Created complete Quality System.

Achieved ISO 13485 registration.

Responsible for receiving inspection, MRB, production

release, supplier selection, engineering design controls, and mfg engineering.

EDUCATION/CERTIFICATIONS

A.S. Electronics - apprenticeship program - Tricounty HS, Franklin MA

Green Belt Certified, ISO 13485 Certified, FMEA Certified, Lean Certified



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