Quality Engineering Manager Resume Example
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QUALITY ENGINEERING MANAGER
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
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Experience
Somalogic | Boston , MAQuality 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.
Amerant Bancorp Inc. | Miami , FLDirector 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.
Cavro (Tecan Systems, Inc.) | 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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