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Engineer Quality, Manufacturing & continuous improvements engineering

Rogers, MN, 55374
May 23, 2020

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***** ******** **** #*** 770-***-****

Rogers, MN 55374

OBJECTIVE: Sr. Quality or Sr. Manufacturing or Continuous Improvement Engineer.

Proven abilities in managing large tooling capital equipment programs, tooling troubleshooting, medical product manufacturing, production set-ups and capability studies utilizing Mini Tab software.

Expertise in providing support to Quality, Engineering and Manufacturing shop personnel and customers through problem analysis and resolution.

Experience with applicable quality tools such as Pareto, FMEA, SPC principles, Histograms, Trend Analysis, Process Mapping, Design of Experiments, Cause and Effect Diagrams, 5 WHY, PDCA, A3 projects & Six Sigma. Knowledge of Optical comparators, Keyence programming

Familiarity with ISO 13485, 9001 and AS9100


Sr. Quality Engineer- (Medical equipment)

Duties: Participate in evaluating methods and equipment to meet performance and quality requirements. Establish quality plans for equipment and processes for general and specific product performance needs. Develop and lead execution of gage, process and machine capabilities studies involving Type I and Type II process capabilities using Minitab software. Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes. Prepare inspection reports, QCC, FAI, set-up sheets, PPM and quality alerts for production issues. Applying ISO and QSR requirements to processes and procedures, working with customers such as Stryker, DePuy, Zimmer, Boston Scientific, Wright Medical, Medtronic among others and suppliers on new product introduction to ensure that quality and performance requirements are fulfilled. As part of MRB product team assist with root cause analysis with accountability to resolve problems. Conduct training on root cause and problem solving for quality lab and production floor personnel. Assist in maintenance of process FMEAs and control plans. Created responses for internal and customer complaints using NCR and CAPA process.


Sr. Quality Engineer

Duties: Significantly improving quality, operating efficiencies and reducing operating costs of manufacturing through application of Quality tools.

Identifying waste reduction and process improvement opportunities based on analysis and monitoring of key process control indicators and corrective action.

Create quality documents in compliance with the company’s quality system requirements. Developing internal manufacturing and receiving inspections and maintain records to ensure a high-level performance from suppliers and assure corrective action to resolve problems with purchased parts and material. Conduct capability studies and Gage R&R analysis and certify first article inspection results (PPAP). Make recommendations to product engineering to improve quality of products and/or processes. Write quality plans in support of new product introductions. Contact and/or visit customers and suppliers when necessary to confer on specific quality problems. Drive root cause analysis skills deep into organization and assist new Green Belts with projects correlated with Continuous Improvements. Knowledge of M1 and Oracle ERP management system.


ANDERSEN STORM DOOR, Des Moines, IA (5/12 – 9/13)

Sr. Process/manufacturing Engineer

Duties: Act as Project Team Leader on the development of manufacturing processes for new products. Develop robust manufacturing processes, proven out using statistical methods. Provide design for manufacturability input. Work with manufacturing during product/process development to ensure a successful hand-off from engineering to manufacturing. Work effectively with other team members to ensure high-level project goals are met. Establish effective and efficient manufacturing plans, including work instructions, inspection plans and standard work. Continuously improve fabrication processes.

HON INDUSTRIES, Muscatine, IA (4/10- 5/12)

Sr. Quality Engineer

Duties: Participate and lead quality walks as a response to customer complains.

Provide quality training in key areas to current and new members. Develop and implement standard problem-solving methods. Develop simple comprehensive data analysis tools to indentify top Quality issues. Provide timely reports and drive closure to open quality issues. Drive containment, corrective action and implement poke –yoke. Participate and lead RCI events and A3 projects. Apply Lean and Six Sigma methodologies/tools to improve processes, which result in high quality, low cost quality services and meet customer expectations.


Manufacturing Engineering Manager

Manage department with 9 manufacturing, industrial and tooling engineers who provided daily support for three shifts plant operations.

Responsibilities of the department included support of new product introductions, capital equipment and new tooling justification for stamping, injection molding, plastic extrusion and vacuum forming, foaming, ordering and implementation, assembly line balancing, conversion cost savings and lean manufacturing activities including Value Stream Mapping and Kaizen events.


Sr. Project Engineer - Division Manufacturing

Provided support for new product development efforts, served as liaison between Engineering, Research and Development, and Operations.

Responsible for transition of new product introductions from Engineering to Manufacturing, including capacity analysis, process robustness and process validations. Conducted PFMEA and manufacturability reviews for new products.

Specified and procured new equipment and tooling needed to meet production and quality requirements.

EDUCATION: New Jersey Institute of Technology, Newark, NJ

Master of Science Degree in Mechanical Engineering Graduated 5/86

Polytechnic Institute, Minsk, Belarus.

Bachelor of Science Degree in Manufacturing Engineering Graduated 9/79

ADDITIONAL 3 years of classroom and field training in 6 Sigma.

Black Belt Certified. - June 2005

Project Management Professional certificate-July 2006

TRAINING: Ergonomic Training certificate –June 2013

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