Cara Beougher

Results-driven Quality Management System (QMS) professional with a proven track record in global harmonization, leading teams to achieve a 35% reduction in non-conformance rates at Medtronic. Expertise in regulatory compliance and culture transformation has significantly elevated quality performance and organizational health. Proficient in implementing quality initiatives aligned with GMP, FDA QSR, IVD, and international regulations. Effective communicator skilled in collaborating with stakeholders and regulatory bodies to meet organizational goals.

• Certified Quality Auditor, American Society for Quality (ASQ)
• Medtronic Certified Lean and Six Sigma Green Belt
• Trained in SAP and PLM

• Medtronic, Eatontown, NJ, True, Senior Director Global Quality (Mergers & Acquisitions), 01/01/22, 12/31/23, Led the tactical development and deployment of quality strategy for newly formed Quality Operations M&A Center of Expertise (COE) and executed global process improvements aligned to company’s business strategy & objectives., Minimized field actions, FDA 483s, manufacturing escapes, and costs via early identification of quality risks, creation of risk remediation plan, and integration of complex multi-technology product portfolios into Medtronic’s QMS with harmonized goals., Steered successful QMS integration of drug-eluting bioabsorbable sinus implant acquisition three months ahead of schedule by championing the use of VAVE concepts to improve product function and manufacturability and alleviate quality risks., Senior Quality Engineering Director (Multi-Site Quality Leader - Diabetes), 01/01/20, 12/31/22, Owned end-to-end quality-related operations of multiple commercial manufacturing facilities, including microbiology and analytical laboratories across U.S., Puerto Rico, and China for $2B global diabetes product line., Drove seamless execution of site commitments by directing 200+ employees, resolving complex technical issues, promoting strong quality-driven culture, and analyzing organizational capabilities., Maximized compliance with integrated QMS for multiple manufacturing facilities across several geographies through collaboration with regulators and facilitation of internal and external audits., Optimized engagement and organizational health through development and leadership of a high-performance engineering team of 12 FTE increasing engagement, inclusion and innovation scores from the 30s to the 90s., Slashed non-conformance rate by 35% and reduced scrap by 40% through revamp of high-risk manufacturing areas via execution of sustainable process improvements, standardization, and integration across production lines for manufacturing facility with low quality performance., Enabled resolution of FDA warning letter following re-evaluation by formulating and executing a plan to eliminate deficiencies related to product design and complaint handling.
• Medtronic, Eatontown, NJ, Director of Quality Systems (Multi-Site Quality Leader – Spine & Biologics), 01/01/14, 12/31/20, Provided end-to-end quality and audit program oversight for multiple manufacturing & distribution facilities, including management of microbiology, analytical, and animal laboratories., Served as co-creator to design Quality Begins with Me (QBwM) cultural assessment tool; deployed and trained enterprise manufacturing facilities, resulting in improvement in quality culture globally., Reduced site CAPA volumes by 70% in 10 months through complete revamp of CAPA process, implementation of process flows, introduction of root cause analysis tools and improved responsiveness to quality issues., Generated cost savings worth $1M+ and reduced cost of poor quality by decreasing sterility failures, optimizing contamination control and cleaning efficacy, and driving process improvements for aseptic manufacturing facility in ISO Class 5-8 clean rooms., Secured approval for first advanced bone graft in Japan, obtained Medtronic Beacon Award, and attained a projected CAGR of 6.5% by initiating bone graft product in Japan as part of a quality and regulatory initiative in partnership with colleagues and Japanese regulators.
• RK Manufacturing Corp., Danbury, CT, Senior Quality Compliance Manager, 01/01/14, 12/31/14, Facilitated effective development and clinical testing of new products via introduction of an internal quality system, integrated with post-market surveillance and complaint handling for device and machine tool development contract manufacturer., Elevated operational efficiency via utilization of lean concepts and techniques in collaboration with R&D and Operations., Optimized employee training program by rolling out cross-functional internal audit program to incorporate competency testing and ensuring compliance with regulatory requirements.
• Pinnacle Transplant Technologies, LLC, Phoenix, AZ, Vice President, Quality & Regulatory, 01/01/11, 12/31/13, Rendered expert-level technical competence for new human bone putty technology, navigating it from development through commercialization., Oversaw all key clinical, quality and regulatory operations, including packaging, engineering, validation, UDI / labeling, documentation, change control, CAPA, nonconformance management, training, vendor management, post-market quality, and complaints., Contributed to complying with company’s strategic objectives by devising and implementing quality operations excellence strategies., Obtained industry accreditation as well as domestic and international regulatory approvals by structuring quality and regulatory program from the ground-up startup tissue bank., Drove maximum operational and regulatory adherence by deploying employee training program and delivering ongoing guidance to staff on quality improvement processes.
• Lattice Biologics, Scottsdale, AZ, Vice President, Quality & Regulatory, 01/01/10, 12/31/11, Designed and developed 15,000 sf ISO class 5-8 clean room facility to support manufacturing operations and meet customer demand for startup tissue bank., Created plant quality management system, including all operations procedures to comply with standards and regulations., Senior Director, Quality & Regulatory, 01/01/08, 12/31/10, Clinical & Medical Affairs Director, 01/01/05, 12/31/08