Consultant
Talented, innovative, and energetic professional with solid quality engineering and process improvement expertise. Highly credentialed with years of experience working with leading, global medical device and biotechnology manufacturers. Background in needles, syringes, blood glucose meters, filters, drug eluting/bare stents, catheters, guide wires, biopsy forceps, hydrothermal ablation and pelvic floor products.
CORE COMPETENCIES
- Quality Engineering Methods/Tools
- Statistical Analysis/Methods/Tools
- Sampling Plans/Rationale
- Risk Management/Risk Analyses
- Design Controls/DHF Documentation
- Production/Process Controls
- Process Improvement
- Training Programs
- Quality System Development
- Procedural/Work Instruction Development
- Auditing/Gap Analyses
- Quality System Compliance
- Root Cause Investigation/Analysis
- Cost Reduction/Waste Reduction
- Acceptance Activities/Test Methods
- 21 CFR Part 820/ISO 13485/ISO 14971
SELECTED ACCOMPLISHMENTS
- Provided leadership and technical expertise for project dedicated to complete re-engineering of risk management system for global medical device company including software solution, policy, procedures, work instructions, and training, resulting in streamlined risk management system that focused on patient safety and shared risk information across related product lines
- Contributed to development of design control training for global medical device company and participated in delivery of said training resulting in current, compliant, and consistent design control practices across organization
- Participated in project to remediate all historical process validations performed by global medical device company resulting in identification and mitigation of gaps
- Developed and delivered technical training on various statistical techniques within several global medical device companies resulting in increased data driven decision-making across multiple functions
- Lead process characterization studies for global biotechnology support company resulting in more in depth understanding and tighter control of process parameters
- Developed and implemented method for identifying out of control process conditions needing further investigation prior to product release to global biotechnology company resulting in increased customer satisfaction and closure of audit findings
- Performed detailed gap analysis to identify where manufacturing practices differed from standard operating procedures and mitigated said gaps resulting in compliant practices and procedures
- Developed Six Sigma Program for global medical device company complete with rollout strategy, training curriculum, training schedule, project selection strategy and project definition guidelines
- Identified dimensions that significantly contributed to function of medical device product resulting in reduction in number of dimensions considered critical and requiring measurement by 67%
- Implemented test fixture and method improvements for global medical device company resulting in significantly improved gage repeatability and reproducibility
- Streamlined sterility testing process of global medical device company for quarterly dose audits resulting in 60% reduction in turnaround time
- Identified root cause Bacteriostasis/Fungistasis testing failures for global medical device company resulting in increased success rate from 0 to 100%
- Revised global medical device company’s corporate microbiology department’s controlled documentation system resulting in elimination of 39% of documents
- Identified wasteful practices used to perform gel clot Limulus Amoebocyte Lysate Assay at global medical device company resulting in reduction of materials and reagents required to perform assay by 80% for annual savings of $255,000
- Implemented new semi-automated turbidametric method for Limulus Amoebocyte Lysate Assay for global medical device company resulting in increased throughput, faster turnaround time, and reduction in materials and reagents required
- Identified root cause Ames Mutagenicity Testing failures resulting in increased success rate from 0 to 100%
PROFESSIONAL EXPERIENCE
- Budreckis Quality Engineering, LLC – 5/12 to Present
- Boston Scientific, Principal Quality Engineer – 5/08 to 1/12
- Boston Scientific, Manager I – 4/07 to 5/08
- Boston Scientific, Principal Quality Engineer – 10/06 to 4/07
- Boston Scientific, Senior Quality Engineer – 11/05 to 10/06
- Millipore Corporation, Quality Engineer III – 6/04 to 11/05
- Abbott Laboratories, Design Control Specialist – 12/02 to 6/04
- Tyco Healthcare, Quality Engineer – 2/02 to 12/02
- Tyco Healthcare, Microbiology Supervisor – 10/99 to 2/02
- Tyco Healthcare, Toxicology Technologist – 10/97 to 10/99
- Massachusetts Institute of Technology, Research Technologist – 10/96 to 8/97
EDUCATION
- Graduate studies, Biology, Northeastern University – 9/94 to 9/96
- BS, Marine Biology, Long Island University – 8/93
CERTIFICATION
- Six Sigma Black Belt, Tyco Healthcare – 11/02
- Quality Engineering (CQE), American Society for Quality (ASQ) – 12/01
TRAINING
- Global Approaches to Risk Management throughout Product Life Cycles, AdvaMed – 5/07
- Leading and Implementing Change Without Pain, Pervasive Learning Solutions – 5/07
- Risk Management in Operations, ASQ Biomedical Division – 2/07
- Risk Management, Regulatory Affairs Professional Society – 12/06
- Risk Assessment and Management, Institute of Validation Technology – 6/06
- Gamma Radiation Sterilization, PTi international – 3/05
- Internal Customer Service, Millipore – 10/04
- Basic Statistical Process Control, Worcester Polytechnic Institute – 9/04
- Introduction to GMPs and Good Documentation Practices, QCT Solutions, LLC – 8/04
- Creating a Workplace of Champions, Millipore – 8/04
- Product Design for Six Sigma, Breakthrough Management Group – 1/04
- Operation and Maintenance of Tangential Flow Filtration Systems, Millipore – 6/04
- Six Sigma Train-The-Trainer, Breakthrough Management Group – 12/03
- Six Sigma Transactional ToolMaster, Breakthrough Management Group – 11/03
- Six Sigma ToolMaster, Breakthrough Management Group – 10/03
- Design Control Requirements & Industry Practice, AAMI – 9/03
- Software Validation, ASQ Biomedical Division – 6/03
- Six Sigma, Tyco Healthcare – 2/02
- Validation Fundamentals, Validation Technologies, Inc. – 11/01
- Taking Corrective Action, Tyco Healthcare – 8/01
- Coaching for Optimal Performance – 8/01
- Internal Auditor, Tyco Healthcare – 5/01
- Cost System, Tyco Healthcare – 5/01
- Dealing With Emotional Behavior – 5/01
- Recognizing Positive Results – 5/01
- ISO 9002 Refresher, Tyco Healthcare – 5/01
- Respect in the Work Place, Tyco Healthcare – 2/01
- Hazard Communication, Tyco Healthcare – 11/00
- Personal Strategies for Navigating Change, Tyco Healthcare – 11/00
- ISO, Tyco Healthcare – 11/00
- Giving Constructive Feedback, Tyco Healthcare – 8/00
- Getting Good Information From Others, Tyco Healthcare – 8/00
- Behavioral Interviewing, Behavioral Technology™ A Provant Company – 8/00
- ISO 9002 Train-The-Trainer, Tyco Healthcare – 4/00
- Basic Supervisor Skills, Embry-Riddle Aeronautical University – 2/00
