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Quality Engineer Medical Device

Location:
Middletown, DE
Posted:
March 19, 2019

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Resume:

JACQUELINE GERRY

*** ********* ******* **. ********, Delaware 197**-***-***-

**** ac8t4c@r.postjobfree.com

ABOUT

Highly competent Supplier Quality Engineering Specialist with a demonstrated history of working in the medical device industry. Skilled in internal and external auditing (ISO 13485:2016, ISO 9001:2015), change control and document management, supply chain, manufacturing, and corrective and preventative action (CAPA). Bachelor of Science – BS from University of Maryland University College.

EXPERIENCE

May 2017 –

Present

Supplier Quality Engineering Specialist, Terumo Cardiovascular Group

· Determination of new supply sources and supplier quality relations

· Weekly / quarterly meeting coordinator and facilitator (Material Review Board, Supplier Quality Metrics Review, KPI Metric review)

· Maintain site-specific Approved Supplier List (ASL)

· Supplier Non-conformance process: Timely implementation and effectiveness of corrective actions

· Ensure consistency of supplier status and problem resolution

· Supplier selection adds/changes, supplier planning, and documentation collection

· Supplier site evaluations, covering quality system and production line capability

· Corrective and Preventative Action (CAPA)

· Quality Agreement negotiation and execution

November 2015

– May 2017

Quality Assurance Clerk, Terumo Cardiovascular Group

· Facilitated inventory completion and control for multiple Business Units

· Weekly meeting coordinator and facilitator

· Inspection of raw material

· Document Center administration

· Non-conformance processing

· Change control

Page 2

SKILLS & ABILITIES

Planning and organization: Can effectively

plan and manage activities and projects

through to delivery

Time management: Manage time effectively,

assigning priority to tasks and able to work

to deadlines

Written communication: Able to express

ideas in writing clearly and succinctly

Commercial awareness: Can understand

the commercial impact of a business

decision or action

Teamwork and social awareness: Ability to

work confidently in a group and interact

well with other people

Drive and determination: Desire to get

things done quickly, effectively, and

correctly

EDUCATION

August 2016 –

May 2018

B.S., Social Science, Psychology, University of Maryland University College August 2014 –

August 2016

AAS, Social Sciences, Cecil College



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