Medical Device Manufacturing Associate

Kristy Hamrick

Eustace, Texas ***** 903-***-**** adzrm7@r.postjobfree.com

Summary

Performance driven with over 20 years’ experience in manufacturing Control in regulated manufacturing environments. Successful record devising, evaluating, and implementing continuous process improvements to minimize waste and reduce costs while maximizing quality and yield. Strong leadership skills and significant experience in developing people and teams by establishing effective quality control and safety programs, encouraging initiative-taking participation across the manufacturing floor. Success building cohesive teams focused on quality, production goals, safety, and throughput.

Skills & Abilities

· 18 years’ experience working in the medical device industry

·5 years’ experience as a Manufacturing Manager in the medical device industry

·1 year experience as a Regulatory Affairs Associate in the medical device industry

·3 years’ experience as a QC Inspector in the medical device industry

·8 years’ experience as a Manufacturing Associate in the medical device industry

·Excellent organizational skills

·Proven ability to identify, analyze and solve problems

·Proven ability to interpret standards, specifications, and procedural and regulatory requirements

·Enthusiastic, dependable and self - motivated

·Microsoft Office Tools (Word, Excel, Power Point)

·Ability to inspect and manufacture to blueprints (drawings)

·Tools/Equipment: Calipers, micrometers, optical comparator, ruler, pin gages, force gages, OGP, microscope, COF Testing, UV Lights, soldering irons, gluing dispensers, pad printing, stent coating, balloon fiber laying/wrapping, impulse sealers, final packing seals

Experience

PRODUCTION SUPERVISOR ARGON NOV 2021 TO CURRENT

·Planned, organized, and controlled workload and personnel to meet production schedules

·Maintained inventory, cycle counts, and accurate transactions of materials

·Managed daily labor efficiencies and schedule adherence

·Managed and reported weekly KPIs (MUV, Material Usage Variance and Scrap)

·Maintained 6S and safe working conditions in area of responsibility

·Improved methods and processes to improve productivity, reduce costs and improve quality

·Developed, administered, and maintained manufacturing work instructions and activities required to ensure processes and products met applicable quality standards and requirements

·Trained, developed, instructed, and motivated employees to achieve maximum efficiency

·Communicated and ensured compliance to all company policies, standards, and procedures in area of responsibility

·Identified bottlenecks that limited production and implemented corrective actions

·Insured flow of materials to meet production needs

·Ensured proper tools and equipment were available to workforce to complete tasks

·Hired, managed, recognized, and disciplined employees

REQULATORY AFFAIRS ASSOCIATE MEDLOGICS OCTOBER 2019 TO NOV 21

·Developed, administered and maintained Quality System Policies & Procedures and activities required to ensure processes and products met applicable internal, customer, ISO and Regulatory requirements

·Developed, administered and maintained training to Quality Management System (QMS) and Regulatory standards.

·Maintained and administered: Internal Audits, Customer Complaints and CAPAs

·Assist Customers with Foreign Government Submissions for Medical Device Registrations, Brexit, Post Market Surveillance, and REACH Compliance.

·Managed and maintained Document and Record Control Systems.

·Managed and maintained Product Certificates of Conformance/Analysis

MANUFACTURING MANAGER MED-LOGICS INC MAY 2015 TO OCTOBER 2019

·Planned, organized and controlled work load and personnel to meet production schedules

·Maintained safe working conditions and housekeeping in area of responsibility

·Improved methods and processes to improve productivity, reduce costs and improve quality

·Developed, administered and maintained manufacturing work instructions and activities required to ensure processes and products met applicable quality standards and requirements

·Trained, developed, instructed and motivated employees to achieve maximum efficiency

·Communicated and ensured compliance to all company policies, standards, and procedures in area of responsibility

·Identified bottlenecks that limited production and implemented corrective actions

·Insured flow of materials to meet production needs

·Ensured proper tools and equipment were available to workforce to complete tasks

·Hired, managed, recognized and disciplined employees

MANUFACTURING ASSOCIATE MED-LOGICS INC MARCH 2014 TO MAY 2015

·Responsible for assembly of micro-surgical devices using tweezers, bonding agents and microscopes

·Minimized production rejects due to improper handling

·Visual inspections using stereomicroscope

·Maintained cleanliness to cleanroom standards and adhered to cleanroom attire

·Communicated technical issues and defects to supervision

·Complied with company, ISO and FDA standards

ENVIRONMENTAL SAFETY COORDINATOR AMERICAN EAGLE NOV 2011 TO FEB 2014

·Maintained chemicals

·Maintained First Aid Kits and respirators

·Maintained and Inspected Fire Extinguishers

·Maintained and inspected safety harnesses

·Ensured compliance to OSHA and DOT regulations

·Partnered with Continuous Improvement Team to maintain workplace safety

QC INSPECTOR/MANUFACTURING ASSOCIATE FUTUREMED INTERVENTIONAL MARCH 1994 TO SEPT 2004

·Performed inspections of materials, components, sub-assemblies and finished devices at all phases of manufacturing per released specifications.

·Identified product as to the inspection and test status.

·Ability to read and understand specifications and part drawings.

·Utilized and maintained hand tools, calibrated instruments, measuring equipment, microscopes and test fixtures.

·Maintained and controlled environment integrity by using proper attire and adherence to controlled room environment practices and procedure.

·Assisted in processing non-conforming material throughout the manufacturing process.

·Assisted Document Control retrieving and distributing documents

·Assisted Quality Manager with annual record archiving and daily filing

·Manufactured components and finished medical device product as stated in manufacturing work instructions, specifications and drawings

·Maintained a clean work environment

·Worked to improve quality of products

·Identified product not conforming to written procedures or work instructions

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