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Medical Device Quality

Location:
Longmont, CO
Salary:
68k
Posted:
February 04, 2020

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Resume:

Kenneth Charles Kazun

**** *. ******** **.

Apt *0-43

Denver, CO 80204

970-***-****

adblzs@r.postjobfree.com

Profile Summary

• Highly trainable individual with a strong quality, biology and chemistry background.

• Excellent interpersonal, analytical, and organizational skills.

• Strong computer skills (MS Word, MS Excel, MS PowerPoint)

• Experience working autonomously with little oversight while achieving defined goals. Employment History

• Processed incoming product complaints from open to timely completion using procedural guidelines.

• Assessment/submission of complaints for Medical Device Reporting and Field Alert Reporting for complaints against drug products.

• Regularly attended meetings involving changes in protocol/procedure and company focus points/issues to be addressed.

• Worked with numerous other Quality Associates and Management daily to address new situations and continuously increase specified knowledge.

• Effectively communicated with management and Quality Engineers to enhance workflow management and overall job experience.

Northwestern University, Evanston, IL (JAN 2013- APR 2014) Haz-Mat Chemist

• Responsible for the safe collection, segregation and shipment of chemical and biological wastes from Northwestern University’s research laboratories.

• Knowledgeable in Illinois and Federal EPA and DOT disposal codes, regulations and requirements.

• Coordinated with designated members of the Northwestern research community to ensure safe and timely collection of spent/expired chemicals for packing.

• Cross-trained frequently with chemist colleagues to ensure up-to-date protocol was implemented and followed correctly. Attended several training seminars to promote professional development and safety.

• Bacterial, viral and protein expert within the Northwestern disposal group.

• Trained and experienced in donning up to Level B HAZMAT protection for emergency response. Baxter International, Round Lake, IL (JUL 2014- JAN 2017) Product Surveillance Quality Associate I

Medtronic, Boulder, CO (JAN 2017-present)

Quality Analyst

• Responsible for complaint auditing, trending, and closure for designated product lines.

• Assessment/submission of complaints for Medical Device Reporting.

• Communicated with Quality Management to enhance work flow efficiency and reduce works in progress.

• Delegated tasks to new hires and contract employees to ensure autonomy in the absence of immediate management.

• Assessed potential FDA reportable events ad seriatim for severity and reportability. The Home Depot, McHenry, IL (2007-2009)

Garden and Electrical Sales Associate

• Obtained forklift certification, as well as hands on experience in other heavy machinery use.

• Worked directly with departmental and store managers to create the best workplace and customer environment possible.

• Adapted to a multitude of changing job requirements. Education B.S. Biological Sciences (2009-2012)

Northern Illinois University, DeKalb, Illinois



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