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Medical Quality

Minneapolis, Minnesota, United States
November 27, 2018

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Keyoumars (Kian) Imaninaini


Phone: 651-***-****


Production QC Inspector Contract Lake Region Medical Chaska, MN

**//**** – 10/2018

•Receiving instructions from department Supervisor, technician or leads.

•Reviewing parts, Work orders, and/or prints or other written instructions for detail of work to be performed.

•QC inspection of in process and finished medical device products.

•Performing assigned duties per documented procedures, work orders, prints and standard operating procedures (SOP’s), to include asset care, and preventative maintenance requirements.

•Ongoing responsibility for following appropriate procedures for building quality into products.

•Performing set ups on machines, equipment, or operations with assistance.

•Using utmost care and discretion in handling extremely fragile and costly product

•Properly documenting production data.

•Following company practices and procedures.

•Apply and use continuous improvement/lean concepts and practices, such as Rapid A3 problem solving, Hour by Hour boards and 5S methodologies.

•Interacting with all team members to maximize production and quality...

•Performing other assigned duties as specified by supervisor, technician, or leads.

Advanced Manufacturing QA Technician Contract Beckman Coulter Chaska, MN

11/2015 – 10/2016

•Access 2 Instrument Manufacturing Acceptance Testing (IMAT) required releasing an Access 2 Instrument within Manufacturing.

•Inspected parts sent by venders for quality and performance.

•Instrument Setup and configuration. In -Process Acceptance Activities Review.

•Performing Test Analysis and complete QC testing on Access 2 Immunoassay Instrument.

•Work directly with Instrument Manufacturing Technicians, Engineering, and Quality to troubleshoot Instrument related issues on the manufacturing floor.

•Assist engineers complete product performance qualification testing per protocol requirements and quality management system standards.

•Actively provide ideas and feedback to support process, product, and organizational improvement initiatives (continuous improvement).

Regulatory Compliance Specialist Contract Bio Vest International Coon Rapids, MN

4/2015 – 11/2015

•Developed Quality Management Plan (QMP) that documenting the management and operational policies and procedures to ensure work processes, products, or services satisfy expectations and quality standards.

•Inspected all incoming parts used in manufacturing area/

•Provided quality assessment plans to evaluate and improve quality of maintenance production and work processes.

•Conducted evaluations to identify strength problem areas, failure trends, faults in methods and procedures, and other deviations from quality standards.

•Developed local regulations and/or operating instructions for implementation of the quality assurance and reliability program and ensured compliance with procedures.

•Prepared quality assurance operating instructions, local forms, checklists, and other material.

•Acted as a consultant to higher ranking personnel on quality assurance/verification matters.

QA Associate Contract Citadel Floor Finishing Systems St. Paul, MN

6/2013 – 4/2015

•Conducted compliance audits of complex documentation and data. QA liaison for validation and verification activities.

•Inspected al materials and finished products before shipment to customers

•Prepared appropriate agendas and meeting minutes with limited supervision

•Developing, maintaining and reporting department metrics

•Reviewing and assessing appropriateness of document changes in accordance with internal procedures.

•Identifying and leading continual improvement project with cross functional team members.

MDR Specialist Contract American Medical Systems (AMS), Minnetonka MN

2012 – 6/2013

•Completed and submitted regulatory reports within the timeframe mandated by FDA.

•Facilitated complains communication to assess for regulatory reportability and potential impact to patient safety and business operations. Evaluated and identified complains.

•Investigated complains by gathering sufficient data from reports, clinical staff, doctors, hospitals and laboratory analysis at AMS.

•Participated in developing strategies for regulatory reporting decision using event investigation and regulatory decision models.

•Developed internal system, methods, and procedures to maintain compliance and support post market surveillance.

•Participated with writing and developing decision models with changes in product advances or therapies to uphold consistence with mandated regulations under general supervision.

•Evaluated and recommended changes to current systems. Served on multi business teams to evaluate system changes/upgrades. Notified management of report events.

Scientist University of Minnesota, Minneapolis, MN

2008 – 2012

•Performing molecular biology techniques, including: DNA isolation from whole blood and buccal cells, sample tracking, the polymerase chain reaction and SNP analysis.

•DNA genotyping for polymorphisms (SNP) using the polymerase chain reaction, TaqMan analysis and other forms of genotyping.

•Flow cytometry analysis of extracted lymphocytes from blood of patients.

•Reported adverse findings of post heart attack WBC to IRB within the hospital and the sites.

•DNA extraction from Blood and Saliva used for genotyping in Twin Family Study Research at the Department of Psychology Behavioral Genetics.

•Maintained cell culture line for ongoing research.

•Interacting with investigators. Working under FDA/ISO regulated manufacturing environment and following GLP, GMP, and QSRs guidelines. Making manufacturing buffers and diluents according to standard operating procedures for current experiments.

•Identify and work with project partners to implement research design in accordance of the Departments goals, and communicate research results. Collaborate on, coordinate, write, review and edit reports.

Clinical Research Associate (CRA), Boston Scientific, Maple Grove, MN

2000 – 2008

•Involved in on-going Preclinical Research animal studies, focused on treatment of coronary artery disease. Contributed to TAXUS Stent program in Preclinical study trials

•Maintained adequate knowledge and understanding of current scientific literature required to support all product lines and related pre-clinical studies.

•Provided clinical and pre-clinical guidance, strategy, and support for the development of new technologies, new products, extended products claim, and pre-clinical foundation research.

•Morphometry analysis of histology slides.

•Reviewed the reporting related to MDR or ADR from patients complaint, hospitals and doctors.


•Clinical Research Professional (CRP) Certificate

2012, Anoka Ramsey Community College Anoka, Minnesota

•Bachelor of Science, Biology

1993, University of Minnesota, Twin Cities

•2006-2017 Post Graduate Continued Education, University of Minnesota.

Post graduate level classes completed classes II medical devices submissions, clinical

studies trial of medical devices. FDA regulations and standards for class III medical

devices, medical microbiology, biochemistry and medical terminology.

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