Engineer Quality

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Michael R. Tejada

Professional Summary

A highly motivated and hardworking engineer that is well organized and effective at root cause analysis and problem solving. Skilled in decision making, developing and managing projects. Able to work independently or lead teams to achieve business objectives. Detail oriented with great communication skills and experience in an FDA regulated environment focusing on medical devices, manufacturing processes, product design and quality systems.

Skills

Strategic Prioritization and Time Management

FAI Execution, Review and Approval

Microsoft Word, Excel, PowerPoint, Project and Visio

Knowledge of ISO 13485

GD&T

NC/CAPA/Root Cause Analysis

Experience reviewing drawing changes and print designs

Team Work and Training

Project Management

Professional Experience

01/2018 – 08/2019 Stryker Orthopaedics – Mahwah, NJ

Sr. Quality Management Systems Specialist

Executed ERP transition project by establishing transition rules, training, procedure updates and developing new processes for multiple divisions.

Coordinated and established onsite supplier performance to achieve calibration KPIs and metrics.

Spearheaded calibration process and functioned as liaison with Quality and supplier.

Change Control Specialist for quality documents/procedures including training and onboarding.

Headed process improvement and cost reduction projects resulting in over $800K savings in 2018.

Prepared and facilitated audit support for internal/external quality audits.

07/2017 – 12/2017 Stryker Orthopaedics – Mahwah, NJ

Quality Engineer

Headed reduced inspection certification project which yielded over 200k cost savings.

Reviewed and immediately addressed all non-conforming product dispositions.

Coordinated with Supplier Quality and Operation Engineers to assess project plans and meet deliverables including Gage R&R, Supplier Audit Review and NC/CAPA Trend Analysis.

Recommended and executed quality improvements for production and product quality.

Daily activities including gage designs, instrument drawing support, change control review.

Created/Update work instructions and procedures related to manufacturing and calibration.

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001/2015 – 07/2017 Stryker Orthopaedics - Mahwah, NJ

Operations Engineer

Analyzed drawings and performed root cause analysis to determine failure modes of instruments.

Executed process improvement ideas to track, trend and reduce overall quarantines.

Partnered with engineers to investigate issues for root cause and implement corrective actions.

Partnered with Supplier Quality Engineers to drive supplier NC’s and corrections.

Other responsibilities: Organizing meetings, leading projects, change control tasks, manufacturing transfers.

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