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Quality Engineering Manager Resume Example

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QUALITY ENGINEERING MANAGER
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Summary

Customer-focused Quality Engineering Manager with 20+ years of experience in the medical device industry. Successful at building teams focused on driving change, reducing waste and delivering compliant products and services with a high level of quality to meet expectations of internal and external customers.

Skills
  • Leadership
  • Collaboration
  • Auditing
  • US Regulations (21 CFR 820)
  • Risk Management
  • Requirements and Specification review
  • Contract Review
  • FAilure Modes and Effects Analysis (FMEA)
  • Team building
  • Coaching and mentoring
  • Resource Management
  • Root Cause Analysis
  • Quality improvements
Experience
Company Name | City, StateQuality Engineering Manager04/2020 - Current
  • Collaborated with quality team members and other functions to monitor conformance to standards and regulations.
  • Implemented process improvements to quality processes to support efficiency initiatives in operations to ensure customer expectations are met.
  • Participated in annual employee performance review process.
  • Mentor and coach quality engineers to consider the business and our customers when defining or improving processes.
  • Built lasting rapport with internal and external customers and suppliers to foster satisfaction and loyalty.
  • Led root cause investigations to mitigate product and process risks.
  • Demonstrated strong knowledge of company standards and protocols during inspections.
  • Monitored product trends and suggested changes to improve quality and efficiency.
  • Collaborated with other functions to review customer interactions and feedback to maintain high customer satisfaction.
Company Name | City, StateDirector of Quality Assurance, Regulatory Affairs10/2010 - 03/2020
  • Member of senior management.
  • Member of Global QARA team.
  • Supported diverse areas of regulatory responsibility by collaborating with members of the global regulatory team.
  • Liaised with contacts from key customers in the partnering business.
  • Provided key inputs to customer supply agreements.
  • Initiate and drive to closure quality agreements with key customers.
  • Compiled and maintained regulatory documentation and systems e.g. field action files.
  • Designated Management representative for the manufacturing site.
  • Responsible for internal and external audits e.g. customer, notified body and government agency inspections.
  • Planned and oversaw first ever FDA inspection at Tecan Systems.
  • Responsible for site and product registrations to regulatory agency(FDA).
  • Provided review and approval of marketing product literature.
  • Supported diverse areas of regulatory responsibility by collaborating with members of the global regulatory team.
  • Collaborated with cross-functional teams to interpret, communicate and efficiently implement new and revised regulations.
  • Maintained regular communication with Director of Operations to obtain feedback on quality initiatives and to resolve issues.
  • Responsible for for Management Review.
  • Reviewed qualitative customer feedback to address quality issues such as out of box failures. Worked with operations team to identify root causes and implement timely corrective actions.
Company Name | City, StateProject Management Officer08/1998 - 10/2010
  • Defined project plans and timelines, managed workflows, costs, personnel and achieved completion dates on or before scheduled deadlines.
  • Oversight of all project managers to ensure projects are ontime and on budget.
  • Led subcontractor meetings to review project requirements, schedules and cost.
  • Utilized project schematics, drawings and specifications to complete detailed and highly accurate product/design reviews.
  • Enhanced development and drove continuous improvement of project delivery process by providing strong program leadership.
  • Brought projects in on-time and in accordance with budget and quality standards.
  • Collaborated with cross-functional teams to draft project schedules and plans.
  • Built strong community relations with subcontractors and suppliers to optimize cost savings and complete timely release of products.
  • Acted in a dual role as program manager and Project Manager.
Education and Training
De Anza College | City, StateMaster of Arts in Computer Aided Mechanical Design06/1998
  • Summa cum laude graduate
UCSC Extension Program | CityProject Management Certification Program
Certifications
  • Risk Management ISO 14971-2005
  • Geometric Dimensioning & Tolerancing-2007
  • Internal Auditing ISO 9001, ISO 13485-2017
  • Failure modes and Effects Analysis (FMEA)-2009
  • Medical Device: US Regulations (21 CFR 820), RAPS-2010
  • MBA classes for Decision Making & Leadership-2011
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Resume Overview

School Attended

  • De Anza College
  • UCSC Extension Program

Job Titles Held:

  • Quality Engineering Manager
  • Director of Quality Assurance, Regulatory Affairs
  • Project Management Officer

Degrees

  • Master of Arts in Computer Aided Mechanical Design
    Project Management Certification Program

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