• Provides leadership in the role of Quality Lead as part of a multi-functional Global Program Team.• Accountable and responsible for driving decisions and implementing all project Quality objectives and deliverables.• Develops and manages complex project plans, schedules, and associated tasks with your support team.• Reviews functional deliverables and ensures all Quality documentation complies with established policies and procedures.• Ensures product/project risks are identified, communicated, and properly documented promptly.• Provides oversight, review, auditing, an independent voice, and customer advocacy in ensuring compliance to policies, procedures, standards, and regulations.• Participates in team decision-making as the Quality Lead to achieve optimum project results while addressing functional needs/expectations.• Manages resolution of issues through action items captured at meetings in an effective and timely manner.• Manages and leads Quality Element Teams consisting of Quality Subject Matter Experts (SMEs) from all quality functions within Radiology.• Successfully manages projects of medium to high complexity that has a significant impact on organizational and business success.• Manages complex, quality-driven process improvement initiatives within the Radiology organization.• Responsible for initiating assessment/action of identified quality issues/opportunities.• Informs program and support teams of progress, decisions, and concerns promptly.• Periodically updates Global Quality leadership, Research and Development (R&D) Leadership, and Senior Management regarding project progress and critical Quality Assurance (QA) issues.• Provides schedule input and updates and manage relevant functional budgets and resources.• Manages support team meetings, issue minutes, and assigned action items.• Works closely with Global Quality leadership, senior management, and functional management to ensure alignment on project goals and deliverables.

• Led the Supplier Material Review Board daily and worked cross functionally to close NCRs on-time per KPIs.• Assisted with a 9-month reduction of open NCRs from 120 to 15.• Oversaw the Calibration Process at 3 Bayer plants and for all US Field Service technicians. Managed the supplier relationship with calibration vendor including contract negotiations.• Led Plant QA responsibilities for several design transfers/product launches.• During a short time assignment in Project Engineering, successfully led the Product Supply launch of a new version of Bayer’s P3T Injector. Successfully oversaw the transfer of product software across multiple production lines and associated manuals to ensure deadlines were met. Mitigated several raw material supply constraints to minimize impact to production and sales forecasts through various actions. Managed a project to outsource the on-site injection molding of injector components.• During a short time assignment in Supplier Quality, led a project to ensure supplier alignment with design specifications to reduce overall plant risk; developed/implemented change to action plan that reduced timeline by 6 months.• Led Incoming QC/Product Release teams. Successfully reduced both worklist backlogs.• Implemented/managed the DHR Error Correction SharePoint site to streamline and automate corrections.• Implemented automated optical comparator at Incoming QC to improve inspection capabilities.• Assisted with the implementation of cloud-based calibration database for Bayer Australian plant.• Implemented several process improvements related to Calibration/Equipment Control to improve efficiency and manage risk more effectively.• Provided technical feedback related to Calibration/Equipment Control across all levels of organization.• Analyzed/presented calibration data quarterly to plant/global management.• Led numerous CAPAs resulting in effective corrective actions.• Managed Plant QA responsibilities for SAP QA Master Data.

- Worked with Manufacturing Engineering to determine technical solutions for production related opportunities and implemented corrective and preventive actions- Utilized quantitative methods to collect and analyze quality data, recommended potential improvements, and implemented recommended solutions- Understood relevant processes required to accomplish objectives- Planned and managed work activities having significant technical scope with minimal direction- Provided advice and mentoring to less experienced engineers and technicians- Communicated comfortably at all levels of the organization

Fortunate father of two remarkable sons

Lucky husband to an amazing wife

NPD Quality Role:- Facilitated risk management through identification and mitigation using tools such as DFMEA's and fault trees- Facilitated safety, quality & compliance requirements- Provided training and coaching for safety, quality & compliance requirements throughout design process- Interfaced with compliance engineers to conduct safety and risk assessments for prototypes- Developed and implemented product qualification testing- Interfaced with product engineers to develop testing methods and specifications- Evaluated testing results to drive design improvementsSupplier and Production Quality Role:- Evaluated key product performance indicators- Initiated supplier corrective action requests (SCAR)- Facilitated internal corrective and preventative actions (CAPA)- Provided ongoing product production support- Provided coaching/mentoring on key quality concepts- Assisted the quality technicians & supply chain engineers in the evaluation of product returns and introducing of product quality improvements- Facilitated continuous improvement at the supplier level- Provided timely product quality issue mitigation- Evaluated inspection methods & techniques

- Developed new supplier quality related procedures and processes, maintained and improved the existing procedures while ensuring compliance with the requirements of ISO 13485, 21 CFR 820 and other applicable regulations and standards- Investigated and analyzed supplier related quality issues working closely with suppliers and various internal functions to address and resolve the quality issues- Implemented continuous improvement projects at several suppliers- Worked with suppliers to implement necessary supplier corrective actions through the SCAR process- Evaluated and maintained existing suppliers while qualifying new suppliers- Maintained supplier quality metrics- Performed supplier audits and provided support for supplier quality systems improvements- Assisted in developing and maintaining supplier first article, validation, and PPAP submission program- Implemented controls at suppliers to assist with the Reduced Inspection Program- Routinely performed internal audits

Angiotech was acquired by Argon in April 2013. I maintained the same title and responsibilities from my previous employer (Angiotech).

- Applied lean manufacturing techniques to continuously improve cycle times and process flow- Developed, designed, and implemented workplace layout improvements to improve efficiency, quality, and reduce scrap- Chosen by management to travel to Denmark to assist in an operations transfer to the USA- Coordinated trial activities between all functional areas (production, maintenance, quality, materials, and planning) - Wrote standard operating procedures and process protocols- Measured variances to standards, identified variances, investigated reasons, suggested solutions, installed, and followed up to ensure reduction in variances- Conducted monthly meeting with all supervisors and leads for scrap reduction and efficiency improvements- Prepared and analyzed production data for quarterly quality meetings- Updated production job order standards- Tracked process and method changes that reduced inefficiencies and scrap. - Ensured budgeted commitments and goals were met

- Completed multiple process validations in needle grinding, final cleaning, sterile sealing/packaging, and ethylene oxide sterilization cycles- Investigated product related complaints from customers and end-users and implemented appropriate preventive and corrective action when necessary- Annually led several internal audits of production areas- Coordinated with raw material suppliers to ensure compliance with the latest international standards- Completed off-site training courses in process validation, complaint management, quality audits, product development process, sterilization of medical devices, and 21 CFR Part 820

- Conducted biological and environmental studies of contaminated sites- Assisted in construction and maintenance of ground water treatment systems- Performed water sampling to measure contaminant levels- Monitored and analyzed air quality at geotechnical investigation sites- Observed and learned various test methods

- Ensured smooth operation of lab, ordering supplies, autoclaving bio-hazard waste and lab equipment, and preparing solutions- Conducted experiments including gel staining, electrophoresis and spectral analysis