Document Control Quality Assurance
Resume:
Emmanuella Asare
Worcester, MA ***** **********@*****.***
Willing to relocate: Anywhere
Authorized to work in the US for any employer
Work Experience
Quality inspector
IPG photonics.-Marlborough, MA
March 2019 to Present
Responsibilities
. o Perform inspection of the final product according to ISO 13485 standards
o Complete and assure inspection records and all documentation is filled out properly
o Trained to assemble and inspect a variety of products on 5 different lines
o Sub assembly build, transmission, welding, extrusion, coiling, etc according to processes and procedures
o Perform line clearance before new lot starts
o Material handling such as surgical fiber, clamp pad, connector shell bottom and RFID tags .
o Checking each job with lot number and part number before each job starts.
o Perform labeling, and bagging.
Document Control Change Analyst/Training Specialist
Hologic - Marlborough, MA
March 2017 to March 2019
Responsibilities
.Check compliance and quality of documents
.Set up the Document Control system (procedures, processes, templates, applications, etc.)
.Runs & administrates the Document Control system for project or department
.Coordinate regulatory and quality assurance documentation activities (paper and electronic). Identify and interpret relevant regulatory guidelines
.Assist in the preparation and review of regulatory submissions
.Participate in writing and implementing Standard Operating Procedures
.Maintain documentation for procedural document training and related non-procedural training
.Assist in development of Classroom Training Materials, and the delivery to end users as applicable
Quality Assurance Technician
Hologic Inc - Marlborough, MA
April 2015 to 2018
Responsibilities
•Complete and / or review Incoming, In-Process and Final Inspection documentation. (Component Inspection Folders, checklist, release forms, calibration data records etc.).
•Issue Non-Conformance Reports (NCR's) on Nonconformance's.
•Perform detailed review of Device History Records and labels as part of final inspection/release activities for finished product.
•Inspection for field service replaceable units.
•Perform inspections as requested for Engineering and other departments. (First Articles and/or Courtesy inspections) and assist with the development of applicable inspection instructions, checklist, forms and inspection folders.
•Maintain QC Activity Collection Plans and other applicable tracking logs.
•Supporting the Equipment Control as needed which may include activities such as:
•Inspection of fixtures.
•Gathering up and Shipping Equipment out to Calibration Supplier
Quality control and calibration coordinator
Hologic - Marlborough, MA
April 2015 to May 2017
Responsibilities
•Keeping records of all medical product ready to be shipped out
•filing and scanning confidential medical documents
•saving and keeping track of confidential files
•assist quality control team with inspection
.assist calibration team with their field service work
Customer Service
Fitness First Health and Fitness Center - London November 2012 to June 2014
.Provide introductory information to new
Customers
•Greet all guest entering and leaving the facility
•Escalating queries and concerns.
•Following up with customers to see that they are satisfied with their services
•Handle membership database, register new members, and receiving membership payments.
•Handle inbound calls from clients and assisting them with their needs.
Professional Summary
.Highly experienced Document Control and Compliance Professional with vast experience working within the Medical Device industry.
.Managed and monitoring and responding to Document Control mailboxes as well as providing internal user/customer support.
.Strong Ability to communicate effectively with peers and cross functional teams.
.Excellent documentation and customer service skills.
.Detail oriented, self –starting, multi-tasked with superior quality problem solving skills.
Education
Bachelor of Science in Business Administration
Central university college 2018
Bachelor of Arts in linguistics and history in linguistics and history
University of Ghana - Accra, GH 2008 to 2012
Diploma in Business Accounting in Business Accounting
Kumasi Academy High School
2003 to 2007
Skills
•Customer Service (5 years) .Outlook (5 years)
•inventory (5 years)
•Microsoft office (5 years)
•MS OFFICE (5 years) .Medical Device
•Receptionist (5 years)
•Document Control (4 years)
•Data Entry (5 years)
•Document Scanning (5 years)
•Document Imaging (4 years)
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