Quality Engineer - Manage, Maintain, Document & Improve Quality Manage

David Wallace

Clinton, NY *****

www.linkedin.com/in/DavidWallace13323

***********@**********.*** 315-***-****

Quality Engineer

Manage, Maintain, Document & Improve Quality Management Systems

Collaborative problem solver equipped with extensive and diversified quality system management experience. Ensure quality system, process and product improvements are relevant, efficient, effectively implemented and compliant with regulations and procedures. Expert in Corrective and Preventive Action (CAPA) process and assessment, managing CAPA processes, coaching and guiding CAPA project owners through all phases by performing audits, evaluations, and analysis to identify compliance issues and translate into clear, understandable, and attainable steps. Meet commitments with integrity and respect.

Proficiency in:

ISO 9001, ISO 13485, Good Manufacturing Practices (GMP) & Quality System Processes

Quality Management Corrective and Preventive Action Project Management

Auditing Investigations Coaching Non-Technical Partners Tracking

Metric Reporting Customer Focus Green Belt (DMAIC)

Professional Experience

CONMED CORPORATION, ISO 13485, Utica, NY 2007 – 2016

Senior Analyst Corrective and Preventive Action (CAPA)

Provided hands-on management of CAPA system, containing over 60 investigations / CAPAs and supported all CAPA project owners during each CAPA phase. Assessed completion of all CAPA phases, maintained CAPA database (TrackWise), tracked progress and reported on effectiveness of CAPA system used for continuous improvement.

CAPA Phases included; Issue Identification, Investigation (Problem Statement, Containment, Failure Effect, Investigation Detail, Root Cause, Field Impact and Conclusion), CAPA Planning, CAPA Implementation and Verification of Effectiveness.

Achieved positive audit results over extended period, through implementing project management oversight, maintaining strong teamwork relationship with CAPA project owners, and sharing common goals.

Provided training along with approachable and flexible guidance, while working through CAPA phase issues with CAPA project owners, meeting owner needs and progressing towards completion.

Created, authored, and implemented Root Cause Investigation Owner’s Manual for on-demand guidance, reducing investigation rework and variation across CAPA project owners and approvers (Green Belt project).

Investigated, analyzed, prepared, and presented weekly and monthly CAPA metrics, highlighting issues, improving strategy, and driving informed decision making for senior management on CAPA effectiveness.

Improved key CAPA metrics 30% by developing and monitoring early-warning tracking and reporting system of abnormalities, implementing time management skills on those needs with largest benefit.

Developed and maintained electronic CAPA bulletin board, enhancing general CAPA phase knowledge and awareness, and providing important CAPA topics such as upfront planning, time management, cycle times to consider, and lessons learned.

Reduced Nonconforming Report (NCR) backlog 78% from 270 records (over $2M) to 58 ($300K) by facilitating weekly meeting with management to go over reports that simplify current situation and facilitate on-the-spot decisions (Green Belt project).

Investigated component material change on medical device, to reduce complaints for breakage, and reduce related purchasing and assembly costs 20% (Green Belt project).

David Wallace Page Two

***********@**********.*** 315-***-****

ANGIOTECH, B.G. SULZLE FACILITY, North Syracuse, NY 1996 –2007

Surgical Needle, ISO 13485

Quality Assurance Engineer and Validation Manager 2007

Provided quality support for development of verification activities in product validation protocols.

Developed verification plans, ensuring conformance to requirements prior to implementation of manufacturing process changes, and reducing subsequent costs.

QE Supervisor and Quality Engineer (QE) Manager 2000 –2007

Ensured continual improvement activities required to enhance the quality system and tools, as well as worked with manufacturing and engineering personnel in support of the quality function.

Performed audits to ensured compliance to quality system procedures, certifications and training requirements, reporting to senior management the results and identifying areas for improvement.

Collaborative member of cross-functional team, demonstrating effective changes to process or product prior to release, and reducing subsequent costs.

Ensured customer satisfaction through investigation of customer complaints, determining root causes and appropriate action, communicating results, and tracking effectiveness.

Implemented statistical tools to determine process capabilities and sampling plans and created master sampling plan for all inspections, assuring each characteristic was addressed through verification.

Studied surgical needle point specifications and variation to develop and implement process monitoring templates, reducing related customer complaints 30%.

Quality Engineer 1996 – 2000

Provided Quality Engineering support; including process capability studies, sampling plans, quality system development, report writing, quality plan development, and validations.

Generated and implemented many inspection and work instructions documents related to product and quality system, facilitating transition from informal quality system to ISO 9001, and subsequently to ISO 13485, both successfully earning certification.

Performed internal audits, ensuring the quality system and products met requirements.

Developed and implemented quality system documentation, including procedures, experimental plans, inspection methods, and reports required for continuing quality system effectiveness, and meeting customer requirements.

Implemented measurement systems used for tight tolerances, creating several calibration plans and implementing controls to Quality System master inspection plan.

Collaborative member of cross-functional team, demonstrating effective changes to process or product prior to release, and reducing subsequent costs.

Provided hands-on support to inspection, operations, engineering, and new product development, ensuring product quality requirements were understood and verified through development and production.

Implemented ISO 14971, risk management to medical devices, after providing formal training.

David Wallace Page Three

***********@**********.*** 315-***-****

BFGoodrich, Simmonds Precision Engine Systems, ISO 9001, Norwich, NY 1991-1996

Senior Quality Engineer, Customer Programs

Provided general management and leadership of customer quality programs assuring all quality issues were addressed and acted upon from new product design to production of product and processes.

Developed, implemented and maintained product planning system to assure accountability, compatibility and verification with customer requirements to ensure continual release or product.

Presented studies demonstrating effectiveness of quality plan improvements.

Audited product and quality system, identifying improvement opportunities and ensuring customer requirements were effectively implemented.

Performed software validation of automatic test equipment (ATE) used for product acceptance.

Significantly, improved balance between contractual requirements and customer’s ever changing expectations, remaining open minded and sensitive to customer satisfaction.

General Electric Aircraft Engines, ISO 9001, Lynn, MA 1990-1991

Product Procurement Quality Engineer, Electrical Systems

Managed a broad range of procurement quality engineering services, including liaison with suppliers insuring compliance to requirements and control of product quality while inspiring teamwork, integrity and improvements.

Performed supplier ratings, quality system audits, preliminary material review board (MRB) actions and facilitated problem investigations, ensuring supplier performance was accurately reported to management.

Additional Related Experience

BFGOODRICH SIMMONDS PRECISION ENGINE SYSTEMS, ISO 9001, Norwich, NY

Quality Engineer

Education, Training, & Certifications

Bachelor of Technology (BT), Electrical Engineering,

Rochester Institute of Technology, Rochester, NY

ASQ Certified Quality Engineer

ConMed Green Belt ASQ Six Sigma Green Belt

Internal Auditor, ISO 13485:2003

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