Jeff Davis Manufacturing Operations

812-***-**** acz4le@r.postjobfree.com 3425 S. Glasgow Circle Bloomington, Indiana 47403

Senior Engineer and Quality Assurance professional with manufacturing, leadership, quality, and regulatory experience in the manufacturing industry. Proven track record of process development, regulatory compliance, and application of lean principles. Collaborative communicator with strong teambuilding skills while performing operations improvement and increasing quality to ensure higher profits.

Areas of Expertise include:

Quality Assurance

Medical Device Manufacturing

Regulatory Compliance

Design Control

Corrective & Preventive Actions

Risk Management

Operational Efficiency

510k / CE mark submissions

Auditing

Experience & Notable Contributions

INNOVATIVE SURGICAL DESIGNS, INC. Bloomington, IN 2015-Present

Chief Operations Officer

Responsibilities:

Audit systems including Device Master Records, 510k submission documents, and CE mark technical files

Ensure design objectives and deliverables align with product design strategy and compliance standards

Monitor, evaluate, and schedule manufacturing production equipment, personnel and materials

Manage multiple design projects and maintain appropriate regulatory documentation

Develop, prepare, and maintain manufacturing records, operating procedures and OSHA safety compliance

Process Improvements:

Manufacturing process and quality improvements

Waste reduction utilizing lean manufacturing methods

Reduced customer complaints and product changes

GREENWALD SURGICAL CO., INC. Lake Station, Indiana

Director – Engineering & Quality Assurance, (1998-2015)

Responsibilities:

Managed 7 member team in engineering, research and development, and quality assurance departments

Ensure project team procedures, objectives, and deliverables align with FDA and ISO quality requirements

Evaluate technical documentation, identify deficiencies, implement and execute strategies to remediate risks

Focus on manufacturing improvement for increased profit

Process Improvements:

Drafted manufacturing instructions for 2000 machine parts, assemblies, and products, yielding:

o32% cycle time reduction in the manufacturing process for products, components and assemblies

oReduced setup times, the number of setups, and finished product delays

o97.5% reduction in rejections for in-process manufacturing

Implemented maintenance and training programs, and regulatory monitoring provisions, yielding:

oComplete compliance with domestic and international regulations

o67% reduction in customer complaints

ohistory of successful ISO registrar and customer audits spanning 14 years

o76.6% reduction in supplier rejections over 5 years and 57% over 14 years

Introduced maintenance programs and maintenance bi-monthly inspections, yielding:

o70% labor and repair time reduction

oEliminated downtime and dramatically decreased production loss time

Manager – Engineering & Quality Assurance, (1996-1998)

Developed, maintained, and applied regulatory policies and procedures

Increased products to market by 50% by designing and manufacturing new devices and product additions

Directed, developed and implemented quality assurance system (ISO 9001, ISO 13485, QSR, CMDCAS)

Education, Training & Affiliations

Bachelor of Science in Industrial Engineering Technology

PURDUE UNIVERSITY CALUMET Hammond, IN

Associate of Science in Industrial Engineering Technology

PURDUE UNIVERSITY CALUMET Hammond, IN

Certifications:

Machinist, U.S. Dept. of Labor

Lean Six Sigma Certificate, Purdue University Calumet, 2012

Quality Control Certificate, Purdue University Calumet, 2003

Supervision Certificate, Purdue University Calumet, 1993

Professional Associations:

Tau Alpha Pi: Honor Society for Engineering Technology

American Association for the Advancement of Medical Instrumentation

American Society for Quality

American Society of Mechanical Engineers

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