Christine Klein Email and Phone Number

Work with suppliers to analyze and correct any production issues that may occur at supplier site.• CAPA owner to improve supply chain quality system after audit findings.• Manage teams to complete remediation work.• Performed supplier audits at supplier sites.• Develop and author validation protocols and reports.• Summarize reports and write validation reports.• Use of electronic documentation systems (Documentum, Enovia, Indysoft).• Participate in internal and regulatory audits.

Wrote, analyzed, and reviewed test methods and test method validation reports to support the development, receiving inspection, and manufacture of medical devices. • Gather data and performed GAP assessments of existing test method work.• Train new engineers on processes and work instructions.• Develop and author test methods for incoming inspection and manufacturing.• Develop and authored validation protocols and reports.• Coordinate the testing necessary to execute approved validation protocols.• Summarize reports and write validation reports.• Perform evaluations on existing test reports and protocols for completeness and accuracy.• Use of electronic documentation systems (Documentum, Enovia, Indysoft).• Gather data and provide input for internal and regulatory audits.

Wrote and analyzed test methods to support the development and manufacture of medical devices. • Gather data and performed GAP assessments of existing test method work.• Develop and author Test Methods.• Develop and authored validation protocols.• Coordinate the testing necessary to execute approved validation protocols.• Summarize reports and write validation reports.• Audit existing test reports and protocols for completeness and accuracy.• Use of electronic documentation systems (MRCS, Enovia, Indysoft).

Conduct necessary research and apply findings to bring clarity and consistency to Equipment calibration documents through accurate and concise writing and effective use of document format. Write, revise, organize, plan, summarize, edit, and proofread technical documents. Co-author or contribute to the creation and revision of Equipment calibration documents to support Corrective & Preventive Action Quality system record.Plan documents and create the draft or framework of a document for the engineer or team to use as their working document. Review and peer-edit the work of other writers to ensure high quality standards within the technical writing group.Interface cross-functionally within the Calibration & Equipment support teams and throughout the company to acquire source material/information for documents.Use of electronic documentation systems, (Global Workflow, Windchill, documentum, etc), internet research, extensive use of Microsoft Word and Microsoft Excel.

Assembled, and perform implementation processes associated with new equipment, including writing and performing IQ/OQ/PQ protocols and reports. Evaluate current equipment standards in order to suggest and implement improvements.Create or update manufacturing procedures as needed.Write and update Equipment Standards used for maintaining our equipment. Identify and order / reorder equipment components.Perform time studies to identify bottleneck areas or issues that may lead to back order.Work with production operators to address fixturing needs.Assist in training of production operators when process changes occur. Utilize basic statistical techniques to justify conclusions based on collected data.Assist in achieving department and company goals of cost reduction and decreased throughput time by leading continuous improvement initiatives.Follow established safety procedures and perform duties in a safe manner.

Create and maintain item, bill of material and routing product information data owned and managed by Engineering Services within the Andersen Corporate databases utilizing departmental tools and processes.Responsible to make physical changes to database using both manual and automated processes. Ensure data is accurate and consistent with corporate standards through the use of reporting tools and file comparison tools.Communicate data readiness with cross functional groups per project schedule and within the project change process.Gather, understand, interpret and relate change requirements to the physical change needed.Perform special projects/activities as assigned by supervisors, project managers and customers.

Composed and revised packaging and labeling specifications for a major aftermarket packaging project.Work directly with Packaging engineers to update packaging specifications and labeling specifications as required by the project specifications.Create carton drawings using proprietary software.Enter all Bill of Materials into Team Center documentation system and load completed specifications into PDM system.

Work directly with R&D engineers to produce special work orders for assembly on the production floor so Design Verification Testing and Design Assurance Testing was able to be completed and transferred to manufacturing.Assist 2-3 manufacturing engineers for writing and performing design of experiment (DOE), installation, operational and performance qualifications to verify design requirements to allow implementation of procedures to the manufacturing floor.Developed, wrote, updated, released, and trained on manufacturing procedures that contributed to the successful market release of product.Worked with manufacturing personnel to develop and refine manufacturing processes to increase productivity and reduce rejects in the manufacturing environmentIncreased productivity and quality by implementing a visual manufacturing procedure template for production employees.Determined operations required to produce products and develops processes to ensure quality, cost, and efficiency requirements are metDeveloped and introduced a process flow for the manufacturing floor to reduce the production time. Produced quality products by writing clear and concise manufacturing procedures.Successfully developed and implemented routers/travelers for product to travel through production floor.Designed a user friendly manufacturing procedure template adopted for use throughout the company.Investigated issues and devised methods for reducing failures in production.

Assembled, tested and troubleshot assemblies as the devices came were completed after the assembly was completed.Performed initial electrical test and verified assemblies were functional per engineering design specifications.Performed failure analysis and developed corrective actions on non-conforming material from the production floor and returned product from the field.Successfully assembled quality devices in per manufacturing instructions.

* Repair Fax and small copiers at customer site.* Perform regular preventative maintenance on equipment* Repair and diagnose circuits.* Repair hand held dictation machines