Senior Quality Engineer Resume Samples

Description :

1. Led customer quality engineering activities for 50 million parts annually of automotive products including window lift, seat, sunroof, and steering column motors, as well as wiper systems, manufactured in six different Bosch locations worldwide for use in vehicles and sub-assemblies produced at over 50 customer locations in North America.
2. Led cross-functional teams assembled to identify containment, root cause, and corrective actions for zero-mile and field failures of Bosch products using various problem-solving tools and methods.
3. Spearheaded special warranty reduction projects to improve warranty statistics, customer satisfaction metrics, and costs associated with the warranty.
4. Prepared and presented quality data to senior management within Bosch, as well as OEM and Tier 1 customer.
5. Performed annual audits of Bosch manufacturing facilities and their key suppliers.
6. Planned and executed product workshops at customer facilities to train employees on proper handling and testing techniques to prevent defects prior to product launches.
7. Championed various Value Stream Mapping (VSM) workshops to help improve current processes.
8. Implemented various Kaizen ideas to eliminate waste and reduce costs.

Experience

7-10 Years

Level

Senior

Education

Bachelor Of Science

Description :

1. Supervised a Quality Technician and up to seven Quality Inspectors in the management of quality issues in medical device manufacturing.
2. Oversaw the sterilization program for catheters, environmental monitoring of the facility and supervised the instrument calibration program.
3. Described by managers as "a strong performer that ensures the questions are asked to correctly diagnose an issue and he then plans the direction.
4. Used organizational and people skills to resolve quality issues with practical decisions and recommendations to keep production operating.
5. Decreased by 10% the backlog of open non-compliance reports within the 90-day goal.
6. Overhauled a non-functional Bioburden monitoring process to one that was simpler, more manageable and user-friendly in meeting compliance.
7. Established precision limits for the instrument calibration program to address a compliance issue effectively.
8. Embraced rapid and continual changes in a fast-paced, highly regulated manufacturing environment that was making a product in anticipation of plant closure and move to Costa Rica.

Experience

10+ Years

Level

Management

Education

Bachelor Of Science

Description :

1. Lead APQP team during new product launches and responsible for PPAP submissions coordinating activities and reporting to the corporate launch team.
2. Quality Lead / ISO9000 Representative for the Amarillo plant reporting to corporate Quality Manager.
3. Lead Problem Solving and Continuous Improvement teams focused on the implementation of the proper corrective and preventive actions in order to keep the plant indicators meeting the goals.
4. Responsible for Customer Complaints reduction projects were was reached a reduction of 60% meeting our plant goals.
5. Leading development and implementation of PFMEA and Control Plans and Quality Inspections for all plant process.
6. Provided support Developing Supplier helping them to meet our expectations and Quality Standard Requirements.
7. Developed and implemented Quality System, including Quality Manual, Procedures, Instructions, Document Control, Process Controls in order to meet ISO9001 for certification (Certification achieved).
8. A successful lead of Continuous improvement projects getting as result the correction of the principals scraps drivers on the plant.

Experience

10+ Years

Level

Consultant

Education

Bachelor Of Science

Description :

1. Led the project to continuous improvement with applying customer feedback and reducing the error rates and Improving quality and productivity.
2. Benchmarked competitors' product for internal process improvement resulting in a reduction of external failure of the device.
3. Develop positive relationships and effective lines of communication with suppliers.
4. Perform periodic audits of Supplier Quality Systems for the purpose of assuring Supplier conformance to the quality system requirements.
5. Helped Suppliers in effectively executing Supplier Corrective Action Requests (SCARs).
6. Wrote Product Development Proposals to improve the product quality as compared to similar products on the market and meet customer requirements which resulted in decreasing the number of complaint to 55%.
7. Eliminate failure mode with using hypothesis testing and experimental design and warrantied cost saving which resulted in customer satisfaction improvement.
8. Implemented customer feedback and inputs which helped in increasing internal market share by 42 percent.

Experience

10+ Years

Level

Management

Education

Masters of Science

Description :

1. Recruited to develop and manage foundry floor quality; provided guidance and supervision for 50 + molding and cleaning room employees.
2. Review and disposition of overall casting quality, and oversight of quality tool management.
3. Conceptualized, developed and managed the sand testing lab.
4. Developed testing and documentation procedures to communicate testing results throughout the facility.
5. Reduced mold defects by 80% with the implementation of "real-time" sand/binder testing.
6. Instrumental in increasing on-time delivery by 15% with effective supervision of cleaning room.
7. Developed and implemented work standards for molding, cleaning room and heat treatment processes proven instrumental in obtaining acquired AAR certification.
8. Instituted departmental "visual factory" boards showing department-specific critical testing and production metrics leading to increased mold quality and employee awareness.
9. Presented Lean-manufacturing projects to BOD leading to foundry wide procedural changes ranging from labor reporting, mold management, to re-lighting of the entire foundry.

Experience

5-7 Years

Level

Executive

Education

High School

Description :

1. Developed a Construction Safety Management Program to provide in-field, real-time oversight, surveillance, and inspections for FD construction projects.
2. Designed a construction inspection planning/performance tool to track safety inspection performance and record safety compliance issues.
3. Generated a quarterly FD Construction Safety Newsletter to highlight field observations, highlight recurring non-compliance issues, and to provide guidance on the interpretation of OSHA regulations.
4. Generated quarterly trend analyses for construction safety inspections performed.
5. The analyses were utilized to correlate data and identify repetitive trends.
6. Authored "white" papers to promote continuous improvement and consistent implementation methodologies for construction safety programs.
7. Interfaced with multi-discipline design engineers to provide input on conceptual approach, design solutions, and construction implementation.
8. Reviewed facility concept studies, design submittals, (30/60/90%), and constructability assessments.

Experience

10+ Years

Level

Consultant

Education

Masters of Business Administration

Description :

1. Assessed client requirements and prepared Requests for Proposal/Request for Quotation documents for new program proposals.
2. Developed quality procedures, including program quality, testing, inspection, and nonstandard sampling plans.
3. Managed the preventative/ corrective action program for troubleshooting and issue resolution.
4. Ensured compliance with all company procedures, configuration provisions, quality standards, and regulatory requirements.Furnished technical direction, supervision and mentoring to the quality assurance team.
5. Utilized Statistical Process Control methods to control special process capabilities.
6. Supervised contractors and temporary workers, authored inspection/ work instructions and technical documentation, headed product complaint investigations and resolved issues.
7. Provided monthly progress reports to senior management.

Experience

5-7 Years

Level

Executive

Education

Bachelor Of Science

Description :

1. Support different production stages of Pharmaceutical controlled and noncontrolled drugs, encapsulation drugs and also automated packaging lines.
2. Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criterion for obtaining results.
3. Review, approve and support execution of validation protocols and master plans.
4. Investigations to determine cause corrective action and prevention planning.
5. Ensures quality complaints are fully investigated and reported in compliance with SOP.
6. Reviews and approvals of Validation qualifications, Technical Services, Engineering, and Quality Control-Chemistry/Microbiology protocols, procedures, test plans, and summary reports.
7. Provide engineering support in the development and maintenance of the company's quality systems.
8. Assure the receiving and processing of customer complaints are handled in an appropriate manner consistent with all laws and regulations pertaining to patient confidentiality and regulatory compliance.

Experience

10+ Years

Level

Management

Education

Bachelor Of Science

Description :

1. Manage a quality system for this manufacturer of electro-mechanical thermocouple sensors in compliance with ISO 9001-2000 standards.
2. Oversee six quality technicians in verifying specifications, performing quality tests, and conducting failure diagnostics/root cause analyses.
3. Direct a team of union production employees in all aspects of electro-mechanical manufacturing.
4. Plan demand-based production runs for high-volume assembly lines; prepare, adjust, and finalize production schedules.
5. Realize an average cost savings of $100k through applying Demand Flow Technology to improve operating efficiency, through reengineering production, eliminating bottlenecks, and eradicating non-value-added processes.
6. Monitor materials, control inventory, and coordinate delivery.
7. Conduct staff training encompassing all aspects of production processes.
8. Implemented statistical process control (SPC) in the facility and managed the gage calibration system.

Experience

10+ Years

Level

Consultant

Education

Bachelors of Science

Description :

1. Reviewed quality requirements for several new power supply products and ensured that all qualification testing was performed in compliance with customer requirements.
2. Ensured that over $25 million dollars annually were shipped on time and to the highest quality standards.
3. Responsible for initiating the National Aerospace and Defense Contractors Accreditation Program (NADCAP) standards in the electronics and electrical harnessing areas of the business.
4. Ensured that all AS9100 REV C standards were maintained in the Power Conversion business unit.
5. Performed 30+ AS9102 First Article Inspections using Visual FAIR software.
6. Participated in four kaizen functions resulting in 5S implementation in the Sensor and Power Conversion business units, as well as the complete overhaul of the Calibration area.
7. Conducted non-conformance material training, CAPA training, and Material Purge training for all associates.

Experience

10+ Years

Level

Management

Education

Bachelor Of Science

Description :

1. Provide cGMP leadership and direction for the creation of compliant global drug-eluting stent Quality Systems at manufacturing sites.
2. Responsible for determining requirements, identifying gaps, and developing project plans to achieve global cGMP compliant Quality Systems within short timelines.
3. Responsible for developing and implementing procedures for control of materials, batch records, label controls, and others.
4. Responsible for providing Quality direction for developing, writing and executing process validations of both a drug-coated stent process and a polymer manufacturing process.
5. On and off-site cGMP compliance audits at other Boston Scientific sites and contract manufacturing sites.
6. Participation in a number of regulatory inspections as an SME for the approval of drug-eluting stents in various domestic and global markets.
7. Assessing and remediating cGMP compliance gaps in response to an FDA corporate warning letter.

Experience

7-10 Years

Level

Management

Education

Bachelor Of Science