Quality Engineer Mechanical

A dedicated and reliable Manufacturing and Quality Engineer with over 17 years of experience assessing and improving production lines, with particular expertise in the medical devices sector. Carries a proven track record of success in identifying and implementing operational cost savings and productivity improvements while maintaining adherence to strict regulatory standards for FDA and ISO. Excels in directing and leading teams in reviewing large volume of products, ensuring the quality testing process in being performed efficiently and accurately. Eager to apply skillsets to a new and challenging role with a thriving organization.

CORE SKILLS & COMPETENCIES

Quality Control Processes

Production Quality Testing

Manufacturing Procedures

Performance Assessments

Risk Assessments

Regulatory Compliance

Team Leadership

Project Documentation

Process Improvements

CAREER HIGHLIGHTS & NOTABLE PROJECTS

Reduced final testing space by 30% (10K sq-ft.) as a result of 40% increase in productivity and attained 50% product-to-product testing changeover through development of a multipurpose processor simulator and cross-training testing personnel.

Consolidated and integrated identical manufacturing line in a Canadian facility (8K sq-ft.) into a United State facility, reducing duplication costs of same products and facility space by 35%.

Managed a number of internal projects to improve efficiency and effectiveness of operations including identifying the need for weighting solution stations to capture any missing parts or other components in devices before moving to market, and developing a digital vision system to record any changes or implementations that occurred.

Implemented a CPAP Automated Test System and eDHR, allowing the automated system to test up to 450 units daily, resulting in an increase in overall productivity, efficiency, and data contingency compared to manual testing.

PROFESSIONAL EXPERIENCE

Operation Manager Spring Garden Heritage, LLC 2013 – 2018

Notable Responsibilities & Contributions

Effectively managed the investment and resale of foreclosed or high debt real estate properties, working in close coordination with realtors, agents, and suppliers to renovate and move house and apartment units to market.

Managed the renovation and resale of 5-7 houses a year, supervising and assisting with work on site to ensure teams were meeting project deliverables. Assessed all work performed and confirmed materials were employed properly.

Philips Respironics Various Positions Jul. 2007 – Nov. 2013

Senior Quality Engineer Mar. 2010 – Nov. 2013

Quality Engineer Jul. 2007 – Mar. 2010

Notable Responsibilities & Contributions

Managed quality engineering support for medical devices including a CPAP machine, providing effective support in all stages of product development, process validation, product performance qualification (PPQ), and post-market review.

Coordinated and supervised a team of technicians in quality control processes governing a manufacturing line producing 6000 units per day. Assessed team performance, administering annual performance evaluations and reporting directly to director of quality control. Reviewed internal Quality Audits for compliance with Philips system.

PROFESSIONAL EXPERIENCE (cont’d)

Assessed new product development activities including design outputs and manufacturing transfers, process verification and validations (IQ, OQ, PQ), master validation plans, test method validation (Gauge R&R), inspection and acceptance activities, along with ensuring a successful product launch through Manufacturing Quality Plan development, risk assessments, Design FMEA and Process FMEA’s.

Oversaw regulatory compliance efforts, particularly with FDA and ISO standards requirements, drafting necessary instructional materials for any facility changes affecting product quality or work safety, and implemented applicable 21 CFR 820 and ISO 13485 standards.

Managed a number of internal projects to improve efficiency and effectiveness of operations including identifying the need for Weighting Solution stations to capture any missing parts or other components in devices before moving to market, and implementing a Digital Vision system, recording any changes or implementations that occurred.

As a Quality Engineer, led cross-functional teams in performing investigations and resolutions of in support of Delivery Holds, Pilot Run Activities, Non-Conforming products, audit finding, and CAPAs. Implemented mitigation and updated risk assessment documentation, overall reducing the number of open issues by 90% within the first year.

Led processes for continuous improvements of customer satisfaction and requirements compliance, initiating reviews and approval of documentation including: Work Instructions, Quarantines, Investigations, Deviations, Protocols, Complaints, Change Controls, training records and maintaining ISO-9001 /13485 and 14001 compliances.

Developed, evaluated, and improved manufacturing methods, utilizing knowledge of product design, materials, tooling, equipment capabilities and assembly methods.

Accelerated product launch through effective collaboration with NPD, Process Engineering, Production, Regulatory Affairs, Manufacturing and Supplier Quality Engineering teams.

Reviewed and approved ECRs and alerts Engineering Management to the need to allocate support resources for technical change implementation in coordination with Production and R&D.

Reviewed and approved protocols for the validations of new tooling or modified equipment including changes in process, verifications, validations of manufacturing process, assembly, and packaging, where applicable to positively impact the manufacturing process.

Senior Mechanical Engineer Nukote International May 2004 – Jul. 2007

Notable Responsibilities & Contributions

Directed manufacturing staff in coordinating quality control activities for production of printer cartridges and ink toners. Developed training materials for new products and provided presentations relating to test processes.

Generated project and test plans and applied new procedures across multi-disciplinary sectors. Defined and documented acceptance criteria to meet product quality and reliability objectives.

Consistently delivered procedures to reduce operating costs, improve quality, productivity, and increase overall profitability including formalizing training and certification of system test personnel.

Previous Employment

Senior Manufacturing Engineering Xerox Apr. 2000 – Nov. 2004

Manufacturing Engineer Xerox Mar. 1997 – Nov. 2000

Process Engineer Johnson & Johnson Apr. 1996 – Mar. 1997

FORMAL EDUCATION

ASQ’s Certified Quality Engineering (CQE) 04/2018

Bachelor of Science, Mechanical Engineering Technology 1996

Rochester Institute of Technology – Rochester, NY

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