Quality Assurance Medical Device

***** * **** **, *******, AZ ***** • 520-***-**** • *******.********@********.***

V alerie Peterson

O bjective

Seeking a position in the medical device industry suited for an individual with extensive Quality

Management Systems and Operations knowledge and supervisory experience.

S ummary of Qualifications

13 years experience in Quality Assurance in the medical device manufacturing industry

Extensive knowledge of industry regulations, including cGMP, ISO 9001, and AABB Blood

Bank Standards

One of five future leaders selected into Divisional leadership development program

Certifications in Six Sigma Green Belt and ISO 9001:2000 Lead Auditing

Proven problem-solving and project lead capabilities, including root cause analysis, FMEA, and

corrective action implementation; successfully lowering problem rates on various records created

in the blood manufacturing process

Solid expertise in MS Office Suite and Oracle databases

Three years supervisory experience

Exceptional verbal and written communication skills, self-starter, friendly, outgoing and

professional

E xperience

2005 – Present American Red Cross Biomedical Services, Tucson, AZ

Arizona Region

O fficer, Quality Assurance (2012-present)

Performs Quality Assurance functions for the leading blood collection firm in the US in

accordance with FDA cGMP and AABB Standards, specializing in blood collections in the

Western Division, which collects over one million blood products annually.

Involved in extensive problem (deviation) management, including identifying deviations,

root cause analysis, FMEA, CAPA, approving corrective action plans, analyzing and

investigating trends in deviations and reporting Biological Product Deviations to FDA.

Organizes quality auditing of blood collection processes in the Western Division. Reports

findings to senior management and assists in developing corrective action plans to rectify

any unacceptable practices.

Coordinates with blood collections senior management to serve as a conduit for best

practices throughout the division and the organization.

Q uality Associate (2005-2012)

Responsible for leading projects to reduce defect rates in documentation generated in the blood

collection process by utilizing Six Sigma methodology.

Led the Arizona Region’s weekly Quality/Regulatory meeting, where compliance related topics

are discussed and shared with all Regional department managers

2000 – 2005 HyClone Laboratories, Inc., a Thermo Fisher Logan, UT

Scientific Company

P roduction/Quality Assurance Liaison

Ensured adherence of a multi million-dollar medical device production facility to quality

standards and cGMP through documenting deviations and non-conformances, root cause analysis

and implementing corrective actions.

Analyzed records of production batches for technical accuracy in accordance with international

manufacturing standards (ISO 9001:2000) for an accredited facility. Facility manufactured in

excess of 50,000 liters animal cell culture media and bovine serum daily.

Audited internal company processes and procedures in accordance with ISO 9001:2000 and

cGMP. Additionally, responded to external audit observations on behalf of the production

department.

E ducation

Bachelor’s of Science Degree, Biology, Utah State University, 2000

C ertifications

ANSI RAB ISO 9001:2000 Certified Lead Auditor, March 2002

Lean Six Sigma Green Belt Certified, June 2010

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