• Boosts product quality by leading preventive actions and rigorous root cause analyses.• Shapes quality culture by evolving processes to meet future compliance and customer demands.• Collaborates with experts to streamline CAPA activities, ensuring robust quality management.• Pioneers improvements in quality systems, ensuring alignment with regulatory standards.• Leads cross-functional teams to streamline quality processes, boosting compliance.• Scrutinizes and improves quality assurance protocols to exceed medical device standards.• Enhances CAPA efficacy through data-driven performance metrics and trend analysis.• Forges strong partnerships with R&D to integrate quality at every product development phase.• Optimized CAPA process efficiency by 30% through strategic quality system enhancements.

• The Senior Quality Engineer functions as a subject-matter resource for interfacing with cross functional partners in Engineering, Operations, Sterilization, and outside suppliers. • Responsible for Site Corrective Action Preventive Action (CAPA) oversite and leadership. • Led CAPA initiatives, enhancing compliance and reducing risk by streamlining CAPA processes.• Drove quality assurance by leading site CAPA activities, significantly improving operational efficiency.• Evaluated and approved CAPA plans, ensuring robust quality controls and adherence to industry standards.• Championed the adoption of innovative quality engineering practices, elevating product reliability.• Streamlined CAPA processes, boosting compliance and efficiency.• Oversaw rigorous CAPA plan evaluations, ensuring stringent quality adherence.• Increased CAPA response efficiency, reducing resolution times.• Ensured meticulous CAPA documentation, upholding regulatory standards.• Led a team to reduce CAPA cycle time by 15%, enhancing process efficiency.• Pioneered a proactive CAPA approach, significantly mitigating future compliance risks.• Improved operational efficiency through strategic CAPA leadership.• Mentored junior engineers, enhancing team capability and CAPA process adherence.

• Boosted product compliance, directly managed critical customer and CAPA processes.• Oversaw site quality management, ensuring all products met FDA and state regulations.• Strategized quality system enhancements for optimal regulatory adherence and efficiency.• Elevated product quality by leading CAPA initiatives, reducing customer complaints by 30%.• Streamlined quality control processes, enhancing GMP compliance and operational efficiency.• Managed rigorous testing oversight, ensuring all products consistently met stringent specifications.• Guided team in quality assurance practices, fostering a culture of continuous improvement.• Analyzed quality trends to preemptively address potential compliance issues.• Mentored junior staff in quality assurance techniques, boosting team skill levels.• Enhanced documentation practices, improving audit readiness by 40%.• Developed a comprehensive training module, enhancing team capabilities.

Worked as a contract professional in a variety of Quality and Engineering roles in the medical device industry. These roles consisted of Senior Compliance Engineer (Ethicon), Validation Consultant (KIK Custom Products), Technical Quality Leader III (Halyard Health), Senior Quality Engineer (St. Jude Medical), Customer Quality Engineer (Woodward Inc.), and Senior Manufacturing Engineer (Irrimax Corporation).

Ensure site suppliers (API, Sterilization, Raw Materials, Components, and high-risk service providers) are compliant with local and federal regulations as well as B+L Quality Standards:• Established Quality and Joint Venture Agreements, Supplier Risk Assessments and Risk Mitigation planning and Monitoring.• Streamlined Quality Management Systems, reducing complexity and elevating compliance levels.• Pioneered risk mitigation strategies, setting benchmarks in supplier quality and safety.• Championed pre-production quality planning, ensuring superior product launches.• Oversaw new product quality, representing Plant-wide quality interests in strategic projects.• Boosted supplier compliance, certifying 6 key suppliers, enhancing quality standards.• Facilitated superior product launches through proactive pre-production quality planning.• Optimized supplier qualification, enhancing B+L compliance and quality.• Drove supplier risk assessments, minimizing potential quality disruptions.• Initiated quality agreements, setting new standards for supplier collaboration.• Acted as a quality liaison, fostering strong relationships with new distribution centers.• Certified 6 key suppliers, enhancing compliance and quality standards.

Responsible for ISO compliance programs and quality aspects of the medical manufacturing group:• Streamlined ISO compliance, enhancing process efficiency and product quality.• Oversaw FDA QSR adherence and ISO13485:2003, ensuring top product standards.• Guided teams in EPA & CARB testing, boosting product reliability and compliance.• Enhanced product quality by refining ISO compliance processes.• Pioneered safety protocols for UL certification in medical devices.

• Performed Supplier QA benchmarking with outside companies & industries, such as aerospace & automotive for improvement of supplier notification of change process, and Advanced Quality Planning processes.• Conducted supplier quality audits to ISO, FDA or other industry regulatory requirements as required.• Streamlined supplier audits, ensuring compliance with ISO and FDA.• Initiated a Supplier Certification Program to boost quality metrics.• Guided suppliers through quarterly reviews, elevating performance.• Pioneered Advanced Product Quality Planning for supplier development.• Enhanced supplier compliance, reducing nonconformities by 25%.• Developed strategic supplier partnerships, boosting product quality.• Implemented cutting-edge quality tracking tools, elevating supplier standards.• Forecasted industry trends to align supplier quality strategies.• Fostered strong relationships with suppliers to streamline project delivery.• Analyzed supplier data to identify and mitigate quality risks.• Monitored supplier quality KPIs, ensuring adherence to project specifications.• Introduced lean management techniques to enhance supplier engagement and efficiency.

Responsible for coordination of division corrective action & preventive action (CAPA) activities and systems.• Development and implementation of global CAPA strategies and initiatives including rollout of a global CAPA process , policy consolidation, system rollout and training ,• CAPA investigator certification project management and maintenance of the global CAPA communication and benchmarking forum,• Project management of Lean Six Sigma process improvement projects and benchmarking with other organizations/industries.

Responsible for supplier quality management involving suppliers of enteral nutrition feeding device products:• One of sixty individuals chosen to work in a device project management office (PMO) to perform Supplier Quality benchmarking and regulatory gap analysis.• Re-categorized suppliers based upon criticality of supplied components.• Supplier QA benchmarking with outside companies & industries.• Evaluated current supplier metrics for applicability and effectiveness.• Supplier policy and procedure updates to enhance overall Supplier QA performance.• I also led a project for the Development and implementation of global CAPA strategies and initiatives including rollout of a global CAPA process, policy consolidation, system roll-out and training.Boosted supplier QA by leading global CAPA initiatives and system training rollout.• Conducted in-depth supplier audits, enhancing product quality and compliance.• Revised supplier evaluation metrics to improve QA processes and performance.• Partnered with external industries for QA benchmarking, setting performance standards.• Implemented a new supplier categorization system based on component criticality.• Streamlined supplier evaluation to boost QA efficiency and compliance

Responsible for new Product Development Quality Projects involving new hip related products and instrumentation from Design inception to Supplier selection and qualification to post-market surveillance:• Led quality enhancement, saving $120K annually by reducing scrap rates by 20%.• Introduced modern inspection tools, boosting accuracy and efficiency in quality checks.• Developed a dock-to-stock program, integrating JD Edwards MRP, saving over $100K.• Pioneered new risk management system aligning with FDA QSR and ISO 14971 standards.• Coordinated with five departments to implement SPC programs, enhancing process quality.• Led cross-functional teams to streamline product testing, reducing time-to-market.