Quality Assurance Technician Resume

SUMMARY

Dedicated Operations Manager demonstrating effective leadership in all aspects of the job, excels at cutting costs and streamlining operations.
Career has incorporated positions of increasing management and leadership over new product development, quality engineering, regulatory affairs, and complaint and CAPA management which is built on a foundation of clinical patient care and customer support.
Dependable, bringing management and quality experience and a willingness to take on added responsibility to meet tight deadlines.
Enthusiastic team player with a strong work ethic and advanced complex problem solving skills and extensive knowledge in the Quality Assurance field, and planning and scheduling

PROFESSIONAL EXPERIENCE

Confidential

Quality Assurance Technician

Responsibilities:

This company is relatively new and does Orthopedic Instrument repair.
Instrumental getting the company name and brand out to begin increasing sales.
Created Confidential and participated on Quality CAPA teams to conduct nonconforming product root cause analysis and to implement corrective actions to improve manufacturing processes.
Review and approve internal & external supplier special.
Non - special process validation protocols and completion reports for various manufacturing processes.

Confidential

Quality Engineer / Orthopedic Sales Manager

Responsibilities:

Responsible for increasing Sales for this manufacturing company that wanted to grow with very little means of increasing capacity.
Responsible for Quality Engineering support to major product lines for healthcare companies.
Performing complaint investigation, monitoring daily production quality, writing and conducting Process Validations, Vendor surveillance and liaison, supporting international Sourcing and Quality.
Reviewed and approved First Article Inspection Reports.
Generated Non-conformance Reports for products issues, documents.
Reviewed and approved CAPA, their implementation and effectiveness.
Responsible for new business and sustaining current business for the Orthopedic Division of the company. Strengthened the sales of the Orthopedic Division to become the leading division in sales for the company. Created new revenue streams by bringing in new customers and growing current customer base.

Confidential

Operations Manager

Responsibilities:

Design and Clinical Risk Product Management. Applied knowledge of FDA and medical device.
Working effectively in cross functional teams, problem solving and positive approach to teamwork and product excellence and quality.
Performing Risk Management remediation and activities for risk management, relates to design with internal Product Development Engineer to support product, process design and development activities and complaint investigations, and non-conforming materials.
Ensure high level of compliance to FDA QSR 21 CFR 820 and ISO 13485 in all assigned areas.
Working closely with internal departments, Quality Design, Operations, and Research & Product Development to provide support for Design & Clinical risk Management (DCRM) as required.
This was a new start up Orthopedic Company Out Of Switzerland. I was responsible for all aspects of the business for the Columbia City location; ie, production, planning, scheduling, purchasing, quality, engineering, shipping, receiving and all associated personnel over two shifts. This company did $3.5M in the first year of operation.