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Quality Assurance Manager Resume Example

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QUALITY ASSURANCE MANAGER
Professional Summary

Results-oriented strategic leader dedicated to increasing productivity and boosting profit generation. Expert knowledge of Medical Device Standards ISO13485, FDA Regulations, 21CFR820, Aerospace Standards ISO9001/AS9100, and Environmental Standard ISO 14001. Optimizes Quality Assurance standards, policy and procedures by training staff in the Quality Management System (QMS) and implementing corrective actions. Skilled troubleshooter and Managerial techniques who leads teams to success.

Skills
  • QMS Implementation
  • Medical Device Regulation
  • Aerospace Standards
  • Process and Product Defect Analysis
  • Validation Processing
  • Risk Management
  • MRB and CAPA Implementation

  • Effective leader
  • Staff training/development
  • Customer relations specialist
  • Process improvement
  • Results-oriented
  • Procedure development
  • Cost reduction strategies
Accomplishments
  • FDA Process Validation for Medical Device Compliance Complaints, MDRs & CAPA Lean Manufacturing Training Value Stream Processing Training.
Work History
04/2012 to Current
Quality Assurance ManagerLISI Medical Jeropa, Inc. – Escondido, CA
  • Responsible for the direction and implementation of company QMS, Quality Policy and Procedural implementation.
  • Responsible for company compliance,  implementation and training of FDA/ISO Regulatory requirements for Medical and Implantable Devices
  • Company representative during FDA Inspection and ISO Regulatory Audits.
  • Responsible for the approval of all Validated Processes; IQ, OQ, PQ, per FDA and Medical Device regulations and customer requirements.
  • Responsible for coordination, implementation and approval of Process Failure Mode Effects Analysis (pFMEA).
  • Responsible for Quality requirements for new projects per customer standards and specification.
  • Coordinate Audits (internal and external) in compliance with FDA and ISO guidelines.
  • Directed company Customer Complaint, MRB and Corrective and Preventive Action (CAPA) process.
  • Responsible for company COPQ, tracking and reducing within corporate and Quality Policy.
  • Customer liaison for design, manufacturing and complaints.
  • Responsible for supplier control in compliance with Medical Device Industry, customer and company specification.
  • Responsible for training of the Quality Inspectors, GD&T, metrology and establishing company level of inspection acceptance per industry regulation and company procedures.
01/2010 to 04/2012
Quality Assurance ManagerC&H Machine – Escondido, CA
  • Developed and implemented new QMS, Quality Policy and Procedures to ISO9001/AS9100 and NADCAP Regulatory requirements.
  • Responsible for company compliance,  implementation and training of Regulatory and customer requirements.
  • Liaison with customers and regulatory agencies to obtain audit approvals and accreditations.
  • Responsible for quality requirement approval of new product development and process control.
  • Responsible and coordinated customer complaints, MRB and CAPA activities for company. 
  • Responsible for supplier control in compliance with regulatory, customer and company requirements and specification.
  • Coordinate and performed internal audits in compliance with ISO and customer requirements.
  • Responsible for the training of the Quality Inspectors, GD&T, metrology per industry regulation, customer requirements and company procedures.
01/2009 to 01/2010
Quality ConsultantStretch Forming Corporation – Murrieta, CA
  • Developed and implemented the QMS, Quality Policy and Procedures to ISO9001/AS9100 and NADCAP Regulatory requirements.
  • Trained all Quality and Manufacturing departments to the QMS, Policy and Procedures in accordance to the regulatory requirements.
  • Company liaison with regulatory agencies and customers to obtain approval and accreditation.
  • Collaborated with potential "prime customers" to build working relationships and obtain individual approval.
  • Responsible for the validation and approval of all manufacturing processes per customer requirements.
  • Responsible for Customer Complaints, MRB and disposition and CAPA activities.
  • Implemented and coordinated the Supplier Quality program.
  • Performed internal and external audits to regulatory, customer and company requirements and specification.  Responsible for the approval process.
  • Company Quality liaison for all first article and inspection activities with customer representatives.
  • Successfully obtained ISO9001/AS9100 and NADCAP certifications and trained all Quality and Manufacturing departments to the QMS, Policy and Procedures in accordance to the regulatory requirements.
01/2007 to 01/2009
Technical Sales EstimatorVeridiam Allied Swiss – Oceanside, CA
  • Built and maintained dental, prosthetic, and surgical industries client bases.
  • Developed customized solutions with precision machined products and close tolerance manufacturing.
  • Performed audits to ensure that ISO 13485/FDA 21CFR820 requirements and standards were consistently met.
  • Directed internal sales group, advising on sales strategies and tactics, conducting business trend analysis, and forecasting projected sales.
  • Produced comprehensive weekly and monthly sales and operational reports for executive leaders.
Veridiam Allied Swish
  • Facilitated contract expansion by establishing a sales matrix that enabled the customer service group to accurately monitor all sales orders and contracts.
  • Secured and finalized contracts while serving as the new product development engineer.
  • Generated monthly revenue through collaborative efforts with customers to develop new product offerings addressing unique client needs.
  • Served as the key technical liaison between the organization and its clients and assisted with development and production of all new client products.
  • Developed detailed manufacturing cycle time forecasts and established precise cost estimates for product launches by closely analyzing pricing and market trends.
01/1996 to 01/2007
Snap-On Tools – Escondido, CA
01/2005 to 01/2007
International Customer Service Sales and Marketing Manager
  • Directed customer service sales and marketing for international customers, providing exceptional customer service that met customer needs and international business standards.
  • Key Accomplishments:.
  • Saved and reduced monthly expenses by more than 35% by implementing lean manufacturing methodologies to streamline and enhance the quality and production departments.
  • Increased international sales by 13% over an eight-month period.
  • Secured new contracts year over year participating on the new product development team and serving as the company liaison with the customer.
01/1999 to 01/2005
Manufacturing ManagerSnap
01/1996 to 01/1999
Quality Engineer
Education
2011
Associate of Science: Business Management
Colorado Technical University - Colorado Springs, CO
2016
ISO13485::
Requirements:
Affiliations
ASM International SAE International American Society for Quality Control (ASQC)
Certifications
  • ISO13485:2016 Requirements
  • FDA Process Validation for Medical Device Compliance
  • FDA Complaints, MDRs & CAPA Process
  • Lean Manufacturing Training
  • Value Stream Processing Training  
Additional Information

AFFILIATIONS  

  • ASM International
  • SAE International
  • ASQ (65617636)
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Resume Overview

Companies Worked For:

  • LISI Medical Jeropa, Inc.
  • C&H Machine
  • Stretch Forming Corporation
  • Veridiam Allied Swiss
  • Veridiam Allied Swish
  • Snap-On Tools
  • Snap

School Attended

  • Colorado Technical University

Job Titles Held:

  • Quality Assurance Manager
  • Quality Consultant
  • Technical Sales Estimator
  • International Customer Service Sales and Marketing Manager
  • Manufacturing Manager
  • Quality Engineer

Degrees

  • Associate of Science : Business Management
    ISO13485: :
    Requirements :

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