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Quality Manager

Asbury Park, NJ
November 08, 2018

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David G. Siquieros

**** ******** *****

Manasquan, NJ. 08736


Cell 732-***-****

Email –

Career Summary:

Highly motivated, experienced, results oriented professional with significant success in all phases of Quality Assurance/Quality Control and Manufacturing Operations. Experienced in the concepts and implementation of quality/process improvement systems (TPM, ISO 9001/13485, Lean manufacturing, 5S, Value Stream Mapping and Kaizen). Excellent working knowledge of most commercially available PC software (MS office, MS Project and Visio).

2006-2015 WL Gore and Associates Inc. Wall NJ

Medical Device Manufacturing

Manufacturing Leader (Manager)

Member of plant leadership team.

Lead multiple teams of medical device assemblers, grinders and molding machine operators across two shifts in a regulated environment (FDA 21 CFR part 820). Create the financial forecast for each team.

Established and monitored production goals and metrics to measure team and individual performance. Communicate with teams on performance to goals and determine if there are opportunities for improvement.

Implemented OPEX projects on specific production lines. Implemented a self balancing single piece flow process that resulted in a 40% increase in output without adding to head count.

Monitored production yields and cost variances to ensure consistent performance. Investigated and implemented any corrective actions that were identified.

Ensured that all products were produced within the process of record to ensure compliance with the QMS and ISO 13485. Regularly analyzed quality data (training records, NCR, CAPA and SCAR) and ensure compliance to the QMS, legal and regulatory requirements.

Ensure that associates had a documented development plan with specific goals for increasing contributions to the operation and to help develop future leaders.

1994-2003 PolyOne Corporation, Farmingdale NJ.

The leading developer and producer of various polymer products

2001– 2003 Plant Manager

Organized, implemented and monitored the effectiveness of each department including: project sponsorship, production support, escalation procedures and processes, safety and product and process quality.

Developed EH&S and Quality Improvement five year forward plans and established metrics to measure progress. Prepared presentations and delivered progress reports at the corporate quarterly Plant Managers meeting.

Successfully completed 4 years without an OSHA recordable, 2 years without a Customer Complaint and a 28% decrease in internal defects.

Organized and lead cross functional teams to foster effective environmental safety, quality and productivity improvements.

Successfully planned and executed the decommissioning of the PolyOne facility, the transfer of products to alternate facilities and the environmental remediation of the plant. This project was completed 3 months ahead of schedule and 20% under budget.

1997 –2001 Operations Manager

Operational responsibilities for the Manufacturing, Production Planning, Purchasing, Maintenance, Transportation and Quality Assurance Departments, consisting of 120 associates.

Built mutually beneficial relationships with numerous contractors, municipal officials and local police and fire departments.

Lead the safety initiative and conducted training resulting in a significant decrease in OSHA recordables

Ensured the efficient operation of day to day activities with focus on reducing manufacturing costs while increasing output and quality yields. Successfully increased production rates by 15% while reducing quality defects by 28% by establishing and facilitating CQI teams.

Encouraged/developed team work across departmental boundaries and within a four shift manufacturing operation (24/7).

Managed a $28MM budget to ensure capital expenditures were aligned with corporate goals. Was awarded the PolyOne Double Diamond award for exceeding all measurable deliverables

1994- 1997 Quality Assurance Manager, ISO Coordinator, (North America).

Designed and implemented a Quality Management System consistent with the requirements of ISO 9000/QS 9000. Have successfully developed and implemented Quality Management Systems for six manufacturing facilities in the US and Canada (ISO 9001 at two facilities and ISO 9002 at four others).

Generated, manage, and maintained all quality policies, procedures, and records. Lead Management and Design Reviews in compliance with ISO 9000.

Coordinate and manage all Quality Assurance/Control activities for facilities in the US and Canada.

1978-1994 Concurrent Computer Corporation, Oceanport, NJ.

1987-1994 Manager Quality Assurance, Manufacturing and Supplier Quality.

Managed the QA department consisting of three QA Engineers and eighteen QC technicians/inspectors.

Certified as a Lead Auditor for ISO 9000 quality system assessment. Responsible for conducting internal and external audits of the quality management system.

Audited suppliers to ISO 9000, and provide guidance to ensure compliance to the appropriate ISO 9000 standard.

Evaluated Suppliers manufacturing process for critical operations, and make recommendations to ensure compliance with the quality provisions established by CCUR.

Establish a Supplier Certification program designed to assist suppliers in achieving certification to ISO 9000.

Chaired MRB process with focus on scrap reduction, subsystem, and component salvage, and corrective action using a closed loop "Supplier Corrective Action Request" database system for tracking.

Reviewed and acted on supplier changes provided by contract, and investigate changes to products not under contract.

Interfaced with Purchasing and Development Engineering during the selection process for new peripheral and or I/O devices.

Planned and managed high reliability manufacturing projects for select customers.

1985-1987 Senior Quality Assurance Engineer, Product Support and Evaluation.

Responsible for the selection, qualification, and evaluation of all peripheral products and I/O controllers for use with Concurrent systems.

Developed peripheral product quality specifications, and conducted supplier surveys/audits to ascertain the manufacturing capability (Manufacturing and quality systems capability studies).

81983-85 Quality Assurance Engineer, Manufacturing.

Implemented statistical process monitoring and methodology as part of the continuous process improvement policy.

Provide technical training to manufacturing and field service personnel.

Collect and analyze product and process data supplied from Manufacturing, Receiving Inspection, and key customers. Use data to identify potential problems with products, processes, or suppliers, and recommend corrective action.

1980-82 Associate Quality Assurance Engineer.

Provide technical support for processor and peripheral evaluations.

Provide technical support and recommend process improvements for Sub assembly and system level test groups.

1978-80 Technician III through Technician IV.

Sub assembly test and repair of the microprocessor board for Perkin Elmer peripherals.

Sub assembly test and repair of Core and MOS. memory for all current Interdata systems.

1978-79 Prodelin Inc. Heightstown, NJ.

Supervisor, Quality Control.

Supervised four manufacturing test technicians and four QC inspectors for a microwave communications company. Reported directly to the President of the company.

Developed a formal Quality System designed to shift emphasis from defect detection to defect prevention.

Established a design review board to evaluate the manufacturability of new products.

1974-77 United States Navy. Avionics Technician

1974-76 Aviation Electronics and Advanced Avionics & Guidance Systems School.

Naval Engineering Headquarters Unit, Philadelphia, PA and the Broadened Opportunity for Officer Selection and Training Program (BOOST) San Diego CA.

Education: (Major areas of study)


Oneonta State University

English literature

Oneonta State University

Advanced Avionics and Guidance Systems.

Naval Air Technical Training Center Memphis Tenn.

Electrical Engineering Technology

Memphis State University

Business (Marketing).

Monmouth University

Computer Science.

Monmouth University


Monmouth University

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