Engineer Quality

JOHN L. HABERKORN

*** ******* ****, **** * Phone: 608-***-****

Middleton, WI 53562 Email: *******@***.***

Quality Management Professional

Proactive and results-oriented Quality Management professional with proven and demonstrated capabilities in evaluation and investigation of customer-related inquiries and complaints with attention to reliability, safety, and effectiveness. Strong expertise in current knowledge of FDA, ISO, and industry requirements and proven experience in medical device reporting.

Areas of Expertise

Quality Engineer

Non-Conformance

Auditing

Product Surveillance

Training & Staff Development

Medical Device & Pharma

Complaint Review

Policy & Procedures

FDA/MDR Reporting

Six Sigma Engineer

Subject Matter Expert

Complaint Investigation

21CFR Part 210 and 211

21CFR Part 820 and 803

ISO 9001, 13485 & 14001

Laboratory Testing

Calibration and Validation

Federal Compliance

International Compliance

Professional Experience

EVCO Plastics, DeForest, WI December 2016 – May 2017

QA Manager

•Manage a staff of engineers, technicians and inspectors

•Participates in audits and regulatory inspections

•Evaluate processes for updating techniques, quality and overall efficiency to improve the quality and production operations

•Assist the Director of Quality with the development, implementation and maintenance of regulatory procedures

•Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction

•Collaborate with customers to on new product development

NORLAND at SWISSRAY, Fort Atkinson, WI October 2015 - December 2016

QA/RA Manager

•Maintain awareness of all external regulations which apply to the company’s products. This includes safety, performance, registration, submittals, including regulations from International and USA Federal/State Agencies

•Complete all necessary regulatory work, including certification and validation necessary to pass governing regulatory agency standards, obtain certification marks for products, etc. Maintenance of regulatory affairs product files to support compliance with regulatory requirements

•Actively promote regulatory compliance within the company as the way to ensure long term market stability, high customer satisfaction and to protect the company from costly mitigations (recalls and warning letters)

•Perform or take a lead role in internal/external auditing to ISO 13485 requirements, and ensure proper execution of supporting quality system throughout all facets of the operation including closing of findings. Management Representative for any external audits (FDA, TUV)

•Support homologation efforts by international distributors of company products (approval to market, sell and service)

•Provide support to market-released products to include review of labeling, promotional materials, product/manufacturing process changes and related quality system documentation changes

•Prepare 510K (or PMA) submittals to FDA for new/improved claims

•Evaluate field reports and complaints, to determine Medical Device Reporting (MDR) eligibility

•Maintain the Technical File for all company products

•Manage response to adverse regulatory action (recalls, warning letters and customs rejection)

•Monitor Form 2579 reporting process to ensure compliance with FDA and state requirements

VESTA INC, Franklin, WI May 2015 - September 2015

Quality Engineer (Contract Completed)

•Develop, implement, manage and improve the Customer Complaint Program

•Analyze, gather evidence, investigate, track, document and complete complaints through effective and established complaint handling process

•Ensure accurate documentation of evaluation and investigation results with the assigned complaint records

•Develop, implement, manage and improve the internal/external audit programs

•Develop, implement, manage and improve the Supplier Quality program

•Support the investigation and resolution of NCR’s and CAPA’s

•Root Cause Failure Analysis

•Collaborate with Engineering and Customer Support and other appropriate groups for adequate initial evaluation of complaints

•Communicate professionally with customers and/or product end users directly with regards to submitted complaints and to obtain any additional information

PHILLIPS MEDISIZE, Menomonie, WI March 2015 - May 2015

Quality Systems Engineer (Contract Completed)

•Interfaces with sites and their QA organizations to review policies and procedures, regulations and work instructions

•Participates in audits and regulatory inspections (as needed)

•Evaluate processes for updating techniques, quality and overall efficiency to improve operations

•Regularly research and evaluate regulatory trends to ensure compliant systems

•Assist the Director of Quality with the development, implementation and maintenance of regulatory procedures

•Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction

•Collaborate with the stakeholders to ensure proper documentation of the regulations

FRESENIUS MEDICAL CARE, Waltham, MA February 2015 - March 2015

Principle Post Market Surveillance Lead (Contract Completed)

Receives, reviews, processes, and analyzes all product inquiries and product complaints, providing customer support and liaison with manufacturing facilities, distribution centers, technical service, and patients

Serves as mentor and provides guidance to multiple staff based on master symptom code severity

Mentors staff regarding complaint process and serves as Subject Matter Expert on complex issues

Revises and documents Standard Operating Procedures

Ensures complaints are processed in uniform and timely manner based on equipment, drug, or device origin

Apply knowledge of drug and device regulatory requirements to support Post Market Clinical Surveillance efforts

ACCURAY, Madison, WI March 2014 – February 2015

Complaint Specialist III

Analyzed complaints to determine whether an investigation or Medical Device Reporting is necessary according to Canadian regulations, European Vigilance Reporting, or any other worldwide regulatory requirements

Resolved product issues in the field, through coordination of investigations, submitting & initiating CARs & SCARs, recommending customer bulletins

Documented and maintained records of all complaint investigations in accordance with 21 CFR § 820.198

Developed and analyzed trend reports for complaints; communicating results with worldwide customer support

Collaborated with customers/end users to gather additional information as needed to support the complaint investigation

Completed all required customer complaint documentation in an accurate, professional, and timely manner

Effectively implemented the complaint handling process in compliant manner, closing ~300 per week

DEPUY SYNTHES, Warsaw, IN West Chester, PA, Palm Beach Gardens, FL, and Solothurn, Switzerland January 2012 –

March 2014

Senior Quality Engineer/Supervisor (Contract Completed)

Supervised and trained 2nd shift consultants and assigned daily tasks

Under the guidance of the Quality Systems Manager, lead or assisted in conducting audits against FDA, ISO 9001, CMDCAS and/or other international laws and guidelines as required

Worked with company personnel to ensure all QMS documents & records were compliant with required standards

Diligently participated in compliance program-related activities as requested by the Quality Systems Manager

Maintained current knowledge of FDA, ISO, and industry requirements and supervised 24 Quality Consultants

Investigated potential compliance issues and kept management informed of findings

Supervised and trained junior quality consultant staff and assigned daily tasks

Diligently participated in compliance program related activities as denoted by the manager and CCO

Successfully processed complaints in professional and timely manner

Provided reports for initial and supplemental MDRs

Reviewed miscellaneous documentation to ensure any potential hazards are captured in a timely manner

Post Market Surveillance Engineer

Conducted investigation and resolution of approximately 50 product complaints

Effectively communicated with internal employees, sales, and medical professionals regarding complaint status

Performed quality engineering analysis and response for complaint files

Authored explant examination reports and other written documentation for internal and external customers

Supported Product Surveillance Department in investigations & corrective actions from complaints & recalls

BAXTER HEALTHCARE, RENAL DIVISION, McGaw Park, IL October 2011 - January 2012

Quality Engineer II (Contract Completed)

Processed complaint tasks for Renal disposal products, reviewing approximately 50-75 complaints per week, conduct labeling reviews, assign problem and cause codes, determine whether further investigation is needed

Provided support for complaint trend investigations, CAPA investigations and FCA assessment activities

Provided Quality support for device design control and risk management activities

Identified and escalate potential product issues and/or quality system issues and recommend improvements

TERUMO CARDIOVASCULAR SYSTEMS, Ann Arbor, MI December 2010 – July 2011

Quality Engineer, Project Specialist II (Contract Completed)

Initiated and performed defined technical activities leading to new and improved products, processes, or technologies on a program basis

Provided initial triage and root cause analysis of equipment returned for customer reported issues

Reviewed and investigated approximately 100 complaints per week

Project coordinator to improve and enhance the service and repair functions

LIONS EYE BANK OF WISCONSIN, Madison, WI June 2010 - December 2010

Quality Systems Manager

Successfully led a staff of three Quality Technicians

Lead and assisted in front room activities during Eye Bank Association of America and FDA audits

Responsible for the investigation, writing, and submission of FDA MDR (Med Watch 3500) reports

Performed trend analysis for the identification of non-compliant and CAPA reporting

Assisted the planning /implantation of internal/external audits and maintaining Standard Operating Procedures

Maintained the sclera-tracking log, initiate follow-up reports, and perform database entry

GE HEALTHCARE, Madison, WI April 2007 - June 2010

Product Surveillance Specialist

Managed weekly data review of potential complaints, reviewing approximately 100-150 complaints per week

Served as Project Leader for both the Lunar Business Unit and Maternal Infant Care Business Unit

Lead and coordinated product quality activities, and lead reviews of Service Complaint Records to analyze the data for any potentially hazardous clinical safety risks

Developed and implemented a quality metrics device for the Maternal Infant Care Business Unit

Contributed to the Complaint-Handling Unit combining skills in post market regulation, statistics, & product knowledge in trending and handling of incoming complaints for the X-Ray and Lunar business divisions

Facilitated complaint investigation process and helped identify complaints that represent further evaluation

NATIONAL MARROW DONOR PROGRAM, Minneapolis, MN November 2002 – June 2006

Search Coordinator II / Scientific Service Specialist

Planned and administered the search process for hematopoietic progenitor cells from a variety of sources

Analyzed & guided issues concerning search process, health history guidelines, and process improvement

Performed formal review of patient/donor typing ensuring best-matched donors are chosen for confirmatory testing and/or an unrelated bone marrow transplant

Monitored and evaluated the integrity of HLA typing information entered into the Registry

Project coordinator for the research repository insuring adequate samples and inventory existed for potential research requests

UNIVERSITY OF MINNESOTA, Minneapolis, MN December 2001 - March 2003

Application Specialist (Contract Completed)

Performed and implemented equipment, the initialization, and interfacing of systems, and file updates

Trained staff in proper procedural system operation and problem resolution

Completed annual maintenance and daily service to maintain effective equipment operation

Analyzed and troubleshot potential issues and to determine root cause

BAXTER HEALTHCARE, Round Lake Beach, IL September 1993 - November 2001

Quality Calibration Engineer

Supervised four lab technicians, and coordinated the weekly calibration of equipment

Troubleshot all equipment issues to determine root cause and solutions

Utilized Manufacturing & Critical Systems Operations for instrument calibration and validation

Performed area, vendor, and benchmarking audits regularly

Recertified calibration standards with traceability to NIST

Developed SOP's, Out of Tolerance and Out of Limits reports, SOP audits, and composed notebook studies

Research Technician

Evaluated polymer coatings to develop and manufacture powder-free surgical gloves, documenting research

Prepared weekly and monthly reports to evaluate and improve cost effective management procedures

Supervised and trained interns and co-op students

Implemented product testing via computer analysis

Programmed and operated a computer-based automated glove dip-line

Initiated regular maintenance and calibration of equipment used in the production of gloves

Laboratory Technician III

Evaluated testing documentation to verify that critical test processing steps were performed accurately

Fulfilled testing on plasma and blood products, including HB, HC, H1/H2, RPR, ALT, SPE and Western Blot Tests

Troubleshot test systems and equipment making improvements and repairs for flawless operation

Collaborated on the creation of protocols and validations of new testing systems

Performed the training and supervision of all new staff

UNITED STATES NAVY & NAVY RESERVES, Dubuque, IA August 1987 – July 1998

Hospital Corpsman

Developed strategies and oversaw the safety and welfare of individuals aboard ship and the Reserve Center.

Supervised personnel, including their duty scheduling, tasking, and performance.

Performed culture testing to ensure the health and safety of all enlisted and reserve soldiers.

Organized classes and taught CPR.

Maintained, reviewed, and updated all personnel medical records in strict adherence to Navy compliance standards.

Education & Training

Bachelor of Science - Elmhurst College, Elmhurst, IL

Associates of Science - William Rainey Harper College, Palatine, IL

Certification – Baxter Six Sigma Engineer

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