Todd Stephens Email & Phone Number

San Jose, California, US

California, 94086, US

• 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.

Franklin Lakes, New Jersey, US

• 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.

Dahlonega, Georgia, US

• 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.

Greenwich, CT, US

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.

Bridgewater, NJ, US

• 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.

Fort Lauderdale, Florida, US

• 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.

Switzerland 🇨🇭, CH

• 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.

Abbott Park, Illinois, US

• 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.

Abbott Park, Illinois, US

• 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.

Warsaw, Indiana, US

• 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.