Jeanne Cush
Warminster
Summary
A proven regulated industry veteran with over 20 years in manufacturing, my diverse experience in Quality Assurance, Quality Control, Sales and Materials Management demonstrates my ability to meet quality objectives in order to gain new business and provide the customer with outstanding service. My Quality System and business knowledge ensures that under any circumstance, I can meet all company goals.
Overview
42
42
years of professional experience
Work History
Quality Assurance Administration
D&R Machine Company
Southampton, PA
09.2012 - Current
- Perform Quality Contract Review to ensure customer contract and engineering requirements are flowed down accurately within the ERP system to ensure all requirements are met through all of the manufacturing processes. Current customer Base: Boeing, Honeywell, Unison, Northrop Grumman, FN America, NMG, Celestica.
- Perform Quality supplier certifications review and approval to ensure the certifications meet the contract and engineering requirements. Resolve any discrepancies when identified directly with the supplier.
- Perform purchase order review and approval to ensure all raw material or outside processing purchase orders meet all contract and engineering requirements. Validate customer APSL is being properly utilized.
- Balloon drawings and create inspection plans in accordance with AS9102 and AS9100 requirements.
- Perform First Article Inspection documentation in accordance with AS9102. Proficient in Netinspect software.
- Manage customer complaints to ensure RCCA is implemented and effective.
- Led calibration activities on measuring instruments internally and externally to guarantee precise readings and improve overall quality assurance efforts.
- Review and approval of quality management system documentation meets internal and external standards and requirements.
- Worked directly with senior management to ensure team schedules, department projects and quality assurance objectives are met.
- Promoted a culture of continuous improvement through active participation in quality assurance initiatives.
R & D LABORATORY TECHNICIAN
Oliver Tolas Healthcare Packaging
Feasterville, PA
05.2012 - 08.2012
- Temporary contract position reporting to the R & D Manager.
- Develop and perform testing on packaging materials in accordance with internal and external standards and test methods
- Review and maintain electronic and written test results
- Accurately procure, verify and label present and future test samples
- Interface daily with R & D Project Manager to ensure test plan is being met in a efficient and timely manner
QUALITY ASSURANCE MANAGER
Harwood Design
Bristol, PA
05.2002 - 03.2012
- Responsible for all Quality activities for an FDA registered contract manufacturer of medical devices and components.
- Implemented and maintained the Quality System in accordance with FDA Quality System Regulation (QSR) and ISO 13485
- Investigated and resolved customer complaints and instituted corrective and preventive action
- Reviewed and ensured all document change, generation and control procedures have been performed
- Managed the quality control inspectors/technicians
- Supervised and performed inspection of incoming, in-process and final product
- Managed the calibration of measuring and test equipment
- Performed internal audits to ensure procedure compliance
- Initiated training to the applicable staff upon document or procedure revisions
- Outsourced and monitored sub-contracted processes
- Responsible for final product release in accordance with customer specification
- Provided certification of compliance to customers to ensure specification requirements were performed
- Responsible for the review and disposition of non-conforming product
- Performed equipment validations (IQ, OQ, PQ) on new and existing equipment as per 21 CFR 820(i)
- Assisted in manufacturing to meet customer deadlines
SENIOR REGULATORY AFFAIRS ASSOCIATE
Medcomp Inc
Harleysville, PA
08.1996 - 02.2002
- Staff position responsible for preparation of regulatory submissions in accordance with FDA/MDD requirements.
- Prepared and submitted 510k submissions to the FDA, clearance granted
- Prepared rationales for devices to document a regulatory submission was not warranted
- Review and approval of design changes for regulatory impact in accordance with regulatory requirements
- Review of design history files to ensure compliance
- Generate/review device labeling for new and existing products to support regulatory submissions
- Establish material biocompatibility requirements and outsource testing
- Provided customer assistance with regulatory clearance
- REGULATORY AFFAIRS COORDINATOR: Investigate, prepare and concisely compile all documentation to meet the applicable regulatory requirements. Responsible for all documentation required to meet international approval. The above promotion followed.
QUALITY CONTROL TECHNICIAN
Cabot Medical Corporation
Langhorne, PA
10.1983 - 08.1996
- Perform incoming, in-process and final inspection of medical devices and components.
- Establish and document inspection procedures
- Review and disposition of non-conforming product
- Assisted management with complaint investigation and medical device reporting
- Active involvement with new product research and development
- BUYER/EXPEDITER: Responsible for the procurement of components and raw materials for in-house manufacturing. Maintained supplier qualifications and managed supplier performance.
- INVENTORY CONTROL COORDINATOR: Responsible for receiving and processing incoming purchased materials. Performed inventory control duties for work order pick lists and manufacturing issuance.
Education
Associates - Business Administration
Bucks County Community College
Newtown, PAundefined
Pennsbury High School
Fairless Hills, PASkills
- AS9100
- AS9102
- ISO 13485
- FDA 21 CFR Regulation
- Materials Management
- Lean Manufacturing
- Quality Assurance initiatives
Timeline
Quality Assurance Administration
D&R Machine Company
09.2012 - Current
R & D LABORATORY TECHNICIAN
Oliver Tolas Healthcare Packaging
05.2012 - 08.2012
QUALITY ASSURANCE MANAGER
Harwood Design
05.2002 - 03.2012
SENIOR REGULATORY AFFAIRS ASSOCIATE
Medcomp Inc
08.1996 - 02.2002
QUALITY CONTROL TECHNICIAN
Cabot Medical Corporation
10.1983 - 08.1996
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Pennsbury High School
Associates - Business Administration
Bucks County Community College