Quality Systems Engineer Resume Samples

Description :

1. Led Internal auditors group - Ensure VDA 6.3 requirements aligned to our Quality system in order to comply with corporate requirements.
2. Led Management Review (development and carry out presentation) including KPI's, all ISO standards applicable to the organization & legal/corporative requirements as well as the follow up of open action items.
3. Worked with all areas of the organization to develop and implement Ford MP&L and MMOG, towards the Q1 certification, update Ford portals (CQI, MSA, Contacts, Certificates, etc.).
4. Recorded Control management to comply with required disposition on ISO to standards.
5. Established and followed up on internal process audits (LPA) as per CQI-8 and customers' requirements.
6. Developed and performed ISO introduction to all new hires at all levels of the organization.
7. Led Quality Management System documentation processes, including the master document control list, and lead the review, approval, distribution, and training of new or updated procedures.

Experience

10+ Years

Level

Senior

Education

GED

Description :

1. Included the issuing, review, and verification of corrective actions both internal (Corrective Action Requests) and external (Supplier Corrective Action Requests).
2. Included working with the Engineering department on validations conducted on new/changes to processes involved in the manufacture of medical devices.
3. Included performing vendor audits, reviewing vendor surveys and attend vendor visits.
4. Analyzed and closed customer complaints on returned products.
5. Included trending, charting, reporting and initiating corrective action.
6. Trained, coached, and aided the cross-functional team in the creation and maintenance of procedures, work instructions, forms, and other documentation in accordance with ISO9001/ISO13485 standards.
7. Administered the internal audit program and host external audits (ISO, FDA, Customer, etc.) for the North American business.

Experience

0-2 Years

Level

Entry Level

Education

Diploma

Description :

1. Created new Change Orders and approved documents and/or Change Orders.
2. Revised, reviewed, & approved different SOPs (Standard Operating Procedures) either to create, redline or expire/deactivate an SOP in Fenwal's system.
3. Helped transition Warrendale to Fenwals SOPs & assign required training for each role.
4. Created a new form for Warrendale to use when there are product complaints.
5. Led weekly meetings via conference calls to communicate changes or updates on forms & SOPs for Warrendale to use.
6. Created a spreadsheet of a gap analysis on pending change orders that are still open, have issues, or that can be closed.
7. Supported the Global Chemicals sales team with technical expertise and supply chain data for product related or process related inquiries.

Experience

10+ Years

Level

Senior

Education

BS

Description :

1. Handled customer audits, customer feedback, respond to the root cause, and corrective action requests from customers (Boeing, LMI, Magellan Aerospace, Sikorsky Aircraft, Curtiss Wright, GKN, Glencoe).
2. Handled all customer shipments to assure all documentation required is present with hardware being shipped.
3. Created company certificate of conformance for each shipment.
4. Reviewed all outside services purchase orders for accuracy and to make sure all customer requirements are flowed down to suppliers.
5. Rewrote entire company, AS9100 Rev.
6. Drive a systematic approach to quality improvement efforts including root cause analysis and corrective action implementation.
7. Coordinated and trained employees in quality compliance standards.

Experience

5-7 Years

Level

Executive

Education

GED

Description :

1. Traveled to component supplier facilities, performed quality surveillance audits, error proofing services, and made recommendations for improvements.
2. Performed follow up and accepted corrective action reports to ensure completeness.
3. Provided upper management with industry trend information and suggestions for implementation including cost analysis.
4. Conducted source inspections when needed using blue line drawings.
5. Responsible for the accuracy, storage, and retrieval of regulatory documents including weight and balance reports, return to service logbook entries, and support engineering information.
6. Provided regulatory training to company employees in Texas, Wisconsin, and Connecticut.
7. Inspector Performed incoming, in-process, first article, and final inspections on airframe and power plant repairs, alterations, and modifications.

Experience

2-5 Years

Level

Executive

Education

BS

Description :

1. Assisted in new product introduction for project definition of tasks and ownership of actions for completion of work instructions, PFMEA schedule, and control plans; as needed.
2. Maintained NCM database, communicate reported NCM's to suppliers for corrections and dispositions of NCM product; facilitate MRB review boards for disposition of the suspect product.
3. Reviewed incoming PPAP documents and direct as required to responsible parties.
4. Maintained PPAP acceptance database for each product line.
5. Consolidated, reported, updated internal metric boards for Safety, Quality, Cost, and Customer Satisfaction.
6. Provided professional recommendations for refinement of each internal metric.
7. Trained employees on new and existing processes.

Experience

2-5 Years

Level

Junior

Education

GED

Description :

1. Certified Green Belt Certified ISO/TS16949 RABQSA Lead Auditor Trained in Core Tools Performs Managerial Duties/Responsibilities in Quality Manager's Absence Tracks Customer Score Cards on a Daily Basis for Big 3 Customer Portals: GM, Ford, and FCA.
2. Tracked Customer Complaints and Problem-Solving in the same systems to ensure timely processing of Corrective Actions.
3. Tracked and updated KPI's for the entire organization each month that align with the Business Strategy.
4. Trained all employees on the new system.
5. Designed and implemented a Records Management System at GKN that meets ISO and Customer Requirements.
6. Redesigned and Launched an Intranet based system from which all Level 1, Level 2, Level 3, and Level 4 documents can be accessed.
7. Developed and maintained training flex charts per area, by the team for cross-training requirements.

Experience

2-5 Years

Level

Executive

Education

BS

Description :

1. Developed and maintained the Quality Management System of the organization with respect to the ISO 9000 family, ensuring its implementation within various departments and locations across GCC.
2. Developed a strong capability for the organization against ISO and other standards.
3. Facilitated in better alignment of the organization towards international quality standards by conducting ISO 9001 Internal and External Audits.
4. Facilitated the project locations in better performance in quality aspects.
5. Maintained all the necessary documents and records of all the offices and project locations across GCC.
6. Determined and initiated the need for additional Quality System Procedures (QSP's).
7. Identified and maintained a matrix of Quality records to demonstrate compliance with the quality system.

Experience

2-5 Years

Level

Executive

Education

MS

Description :

1. Developed food safety qualification plans to successfully integrate new processes, equipment, line installations, and products.
2. Managed regulatory, religious, and 3rd party audit certification(s): FDA, Kosher, Halal, and GMP/Food Safety.
3. Established and validated CIP processes and SSOPs on all processing equipment.
4. Designed microbiological challenge studies to validate the food safety properties of Torani Syrup formulas.
5. Conducted extensive allergen assessment study on all allergenic raw materials and finished products.
6. Investigated issues found in Raw Materials, WIP (Work in Process), Finished Products, Customer Complaints.
7. Performed Mock Recall/Traceability exercises to trace all products within 2 hours.

Experience

2-5 Years

Level

Junior

Education

GED

Description :

1. Developed and implemented statistical process controls as needed using appropriate quality tools and statistical techniques.
2. Developed positive relationships and effective lines of communication with all functions, suppliers, and customers.
3. Developed, monitored, reported appropriate and effective metrics that monitor the effectiveness of assigned processes.
4. Verified customer QA inspection requirements for all products delivered are being followed with accurate, thorough, and complete inspection records.
5. Assisted Quality Manager with supervising and training needs of quality staff as needed, mentoring personnel to enhance development and growth.
6. Ensured regulatory compliance in all International countries where Torani was sold.
7. Facilitated all customer audits and Corrective action reports.

Experience

2-5 Years

Level

Junior

Education

BS