Medical Device Project

Rachel L. Kremer

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PROFESSIONAL PROFILE

Experienced biotechnical professional with specialized skills and experience; who excels at designing, developing, and implementing innovative and progressive direct quality strategies primarily for global pharmaceutical companies, sites, and CROs.

Strong regulatory and quality background within the pharmaceutical/medical device industry; including familiarity with US FDA GMP requirements, ISO, EU Medical Device Directive, ICH regulations, as well as Lean Six Sigma Green Belt Certification and Advanced Lean Principles and Tools Certification from Purdue University.

EXPERIENCE

Nypro Healthcare, Chicago, IL October 2010 to Present

Quality Engineer

• Leading cross-functional project teams to implement Lean Six Sigma process improvement initiatives set by Executive level teams

• Developing and restructuring of the Quality Management System to ensure conformance with medical device and healthcare industry regulatory standards

• Communicating with clients to re-organize and specify key customer requirements, defining customer specifications and critical to quality features

• Resolving customer complaints and non-conforming products from initiation, escalation, to final resolution via root cause analysis techniques

• Presenting project metrics and timelines to executive level management on a regular basis, persuading management buy-in and support

• Implementing process improvement initiatives to improve process efficiency and reduce overall waste

Perceptive Informatics, a division of PAREXEL International, Chicago, IL October 2009 to Present

Clinical Project Associate

• Ensuring proper documentation of all study-specific material in compliance with FDA CFR 21 regulations and good document practice

• Presenting strategies on behalf of Perceptive to client teams in order to establish buy-in for current and future projects

• Key member of project team responsible for assisting with clinical research study timeline management, quality, and study deliverables

• Coordinating and managing IV/IWRS systems for large-scale projects

• Liaising with clients and updating the study team on progression of assigned deliverables

• Initiating adequate and timely responses to all client enquiries and communication

• Performing validation testing of project specific functionality and assisting with client acceptance testing

Cognitive Drug Research (CDR), Chicago, IL March 2009-August 2009

US QA Auditor

• Independently conducted, reported and performed quality assurance auditing of study-specific critical phases in compliance with company procedures and relevant national and international clinical research regulations and guidelines according to approved schedules and formats

• Applied FDA CFR 21 (including Part 11) regulations and ICH GCP (UK Statutory Instruments and EU Directives) to all aspects of study specific critical phase audits ensuring data integrity, accuracy, validation, and consistency

• Created an SOP cross reference tracker, contributed to CDR’s document control process to ensure that all CDR procedures reflected current practice and GCP compliance

• Ensured that all records were accurately updated on data bases and source documents

• Fostered a culture of GXP compliance and promoted excellence in record keeping and archiving throughout the organization

• Implemented CAPA analysis to all procedures and processes to promote an overall quality driven atmosphere throughout the company

Jones Microbiology Institute, North Liberty, IA September 2006-July 2008

Laboratory Assistant

• Conducted antimicrobial testing according to FDA/cGMP/GLP regulations

• Inventoried supplies, processed specimens, and calibrated equipment

• Tested microorganisms daily against various antimicrobials in accordance with SOP’s

Biomedical Engineering Senior Design I & II Project, Iowa City, IA Fall 2007-Spring 2008

Specialized Design Experience

• Designed motorized canopy for Invacare power wheelchair, performed research relevant to FDA regulations regarding medical devices

• Presented final project to national board, communicating potential avenues to patent the device design

Rachel L. Kremer

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EDUCATION

Purdue University, online continuing education May 2010

Certificate: Lean Six Sigma Green Belt

Purdue University, online continuing education In Progress

Certificate: Advanced Lean Principles and Tools

The University of Iowa, Iowa City, IA Graduated May 2008 Major: B.S. Biomedical Engineering Minor: Business Administration

SKILLS/MEMBERSHIPS

• Hands on experience with Pro Engineering software, Java, and C++

• Proficient in Microsoft Word, Excel, PowerPoint, Outlook, SAS, Minitab, Lotus Notes, and Access database system

• Member of DIA (Drug Information Association)

• Member of ASQ (American Society of Quality)

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