quality assurance manager resume example with 12+ years of experience
- Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
- (555) 432-1000
- resumesample@example.com
- :
I have been a Quality Assurance Manager in the Medical Device Field for the last 5 years. I have experience with management and implementation for the ISO 13485, ISO 9001, and 21 CFR Part 820 standards in relation to medical devices. I have assisted in getting multiple devices 510(k) certified with the FDA. I was in charge of training employees on Standard Operating Procedures and kept detailed logs of such training. I insured constant compliance to all QMS activities. I kept inventory of all products from vendors using a first in first out inventory system which I created. I have been directly responsible for customer complaint resolution, CAPA's and all product recall activities. I have built Product Specification Documents, and revised Formulation Specifications for multiple medical devices. I've reported directly to the CEO, and worked in conjunction with the production supervisor to ensure the highest level of compliance and productivity on the production line.
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- QMS implementation for 21 CFR Part 820, ISO 9001, and ISO 13485 standards for three separate companies
- Assisted in getting a 510(k) for 4 different Medical Devices
- Successfully went through an SGS audit for two separate companies that resulted in an ISO certification with no major findings from a QMS that I implemented
- Handled a product recall that resulted in achieving product dispositions and nonconforming product sent back from 90 vendors in a matter of 72 hours
- Kept thorough logs and handled all customer complaints and CAPA's for the companies
- Worked in conjunction with the Production Manager and CEO to identify multiple issues in manufacturing, and implemented corrective actions resulting in more efficient productivity
- Built an inventory management system and kept accurate product inventory daily using a first in first out inventory system Assisted in building the Quality Management System for three separate companies, two of which have been certified through the 21 CFR Part 820, ISO 9001, and ISO 13485 standards
Schweid – Carlstadt, NJ,
- Performed detailed internal audit of the quality system
- Global reimplementation of the QMS to conform with ISO 13485: 2008 and 21 CFR Part 820
- CAPA implementation/ Root Cause Analysis
- Customer complaint resolution
- Management of the quality control team
- Product Specification design and revision
- Product development, design control, risk analysis, management reviews
- Set up and implemented training program for 60 employees
- 510 (k) certification for class II Medical Device
Schweid – East Rutherford, NJ,
- I was the Quality Assurance Manager for this company.
- I built the regulatory infrastructure for the company.
- Responsible for insuring that the standard operating procedures conformed to the 21 CFR Part 820 and ISO 13485:2003 standards.
- I successfully went through an SGS audit with no major findings resulting in certification.
- I assisted with Design Control and Risk Analysis for a class III Medical Device.
Rho Consulting Services – Somerset, NJ,
- I was responsible for insuring the company conformed to all regulatory standards in conformance to the 21 CFR Part 820 and ISO 13485:2003 standards.
- Assisted in building the QMS from concept to implementation I was in charge of all CAPA's, customer complaints, inventory management.
- Assisted in 510(k) certifications for four different medical devices.
- Involved in design control, risk.analysis, and lead Management Review Meetings.
- Trained all employees in relation to the QMS for the company.
Lineage Logistics – Oxnard, CA,
- I was the owner and operator of a window cleaning company.
- In charge of all marketing, customer relations, and sales.
- Proficient in all applications for both commercial and residential window cleaning.
Quality Assurance, Medical Device, Quality Audits, Product Development, Risk Analysis, Customer Complaint resolution, Product Recall, Inventory Management, CAPA implementation and resolution, ISO, Management, Marketing, Management Review Meetings, Sales
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Resume Overview
School Attended
- Alger Learning Center
- San Clemente High School
Job Titles Held:
- Quality Assurance Manager
- Quality Assurance Manager
- Quality Control Director
- Owner/Operator
Degrees
- High School Diploma
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