Jeanne Cush
Warminster
Summary
Experienced industry professional with over 25 years in Aerospace and Medical Device manufacturing. Expertise in Quality Assurance, Quality Control, Sales, and Materials Management drives the achievement of quality objectives and enhances customer satisfaction. Strong knowledge of Quality Systems and business operations ensures consistent alignment with company goals.
Overview
42
42
years of professional experience
Work History
Quality Assurance Administration
D&R Machine Company
Southampton
09.2012 - 03.2026
- 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.
- Reviewed and approved quality supplier certifications to maintain compliance with contract and engineering requirements.
- 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.
- Managed customer complaints, implementing effective RCCA to resolve issues promptly.
- 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 culture of continuous improvement by actively participating in quality assurance initiatives.
R & D LABORATORY TECHNICIAN
Oliver Tolas Healthcare Packaging
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
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, instituting corrective and preventive actions to enhance product quality
- 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 calibration of measuring and test equipment, ensuring accuracy and reliability in quality assessments
- Performed internal audits to ensure compliance with procedures, identifying areas for improvement
- 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
08.1996 - 02.2002
- Prepared 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
- Investigated, prepared, and compiled documentation to meet applicable regulatory requirements. Managed all documentation needed for international approval.
QUALITY CONTROL TECHNICIAN
Cabot Medical Corporation
10.1983 - 08.1996
- Perform incoming, in-process and final inspection of medical devices and components.
- Established and documented inspection procedures to ensure compliance with quality standards
- Review and disposition of non-conforming product
- Assisted management with complaint investigations and medical device reporting to enhance compliance and product safety
- Active involvement with new product research and development
- Procured components and raw materials for in-house manufacturing, maintained supplier qualifications, and managed supplier performance to support production needs
- 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, PAHigh School Diploma -
Pennsbury High School
Fairless Hills, PASkills
- Quality Assurance initiatives
- AS9100
- AS9102
- ISO 13485
- FDA 21 CFR Regulation
- Lean Manufacturing
- Materials Management
References
Daniel Kasperitis, Quality Control Manager, D&R Machine Company, Direct Report 267-230-3618
Ron Rink, Quality Engineer, D&R Machine Company 215-813-1754
Scott Fera, Scheduler/Planner, D&R Machine Company 267-394-0471
Timeline
Quality Assurance Administration
D&R Machine Company
09.2012 - 03.2026
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
Associates - Business Administration
Bucks County Community College
High School Diploma -
Pennsbury High School