Quality Engineering Manager resume example with 20+ years of experience
JessicaClaire
, , 609 Johnson Ave., 49204, Tulsa, OK100 Montgomery St. 10th Floor
H: (555) 432-1000
C:
resumesample@example.com
Date of Birth:
India:
:
single:
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
Quality Engineering Manager, 04/2020 - Current Somalogic – Boston, MA,
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.
Director of Quality Assurance, Regulatory Affairs, 10/2010 - 03/2020 Amerant Bancorp Inc. – Miami, FL,
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.
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