Consultant   (610) 462-4090   info@qualitysolutionsnow.com Product development leader with experience in small molecule, biologics, and oligonucleotide product development and manufacturing from preclinical to commercial launch. Expert in root cause failure analysis, quality risk assessment, nitrosamine risk assessment, scale-up/tech transfer challenges, and [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Dedicated, well-organized, professional with vast experience in medical device product development, quality management, quality assurance, and quality engineering, regulatory compliance, process and system engineering, manufacturing and supplier qualification. Multi-faceted with thirty-five years of experience in world-class [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Quality Management professional with extensive leadership experience in global organizations and broad background in quality management, regulatory affairs, quality systems, manufacturing, master production scheduling, supplier management and procurement, and research and development. Highly credentialed with years [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Multilingual professional project manager with over 35 years of consulting experience in North America, Latin America, Europe, and Asia focused on supply chain issues with expertise in materials, manufacturing, purchasing, operations, logistics, warehousing, distribution, and regulatory [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Comprehensive packaging development/project engineering background with pharmaceutical companies, world’s leading direct seller of beauty products, and preeminent consumer foods. Leadership, technical, and program management expertise across OTC pharmaceutical consumer products, packaging industries, food, and beverage. Product [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional medical device consultant with solid technical and compliance knowledge, skilled in quality systems, process validation, product development and improvement, and regulatory approvals and submissions. Highly credentialed with years of experience in top global U.S., European, [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional with solid technical and compliance knowledge, skilled in research and development, manufacturing, operations, validation, and quality engineering. Broad experience gained working over twenty years with pharmaceutical, device and biologics manufacturers. Background in the manufacture of [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional with solid technical and compliance knowledge and skilled in product development of Class I, II, and III medical devices. Over 14 years of experience working with global medical device and combination product manufacturers.  Background in [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Highly skilled regulatory affairs and quality assurance professional with extensive experience in combination products, medical devices, and drug/biologic manufacturing. Expertise in regulatory compliance, technical writing, and project management. Strong background in orthopedics, spine, joints, [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional, bilingual consultant with sixteen years of experience in quality compliance, validation and infrastructure systems (Biotechnology, Vaccines and Pharmaceuticals). Broad experiences gained working for pharmaceutical, device and biologics manufacturers.  Background in validation oversight, technology transfer, regulatory [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional with technical and compliance knowledge, skilled in regulatory affairs, quality assurance, operations, and engineering. Highly credentialed with over thirty years of experience working for top global medical device manufacturers. Background in surgical stapling, sutures, point [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Accomplished Global Director of Quality Assurance with over 25 years of expertise in quality management, regulatory affairs, and commercialization of combination products and medical devices. Proven track record of managing quality assurance teams and driving compliance [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Accomplished professional skilled in operations, distribution, supply chain, logistics, production, warehousing, and packaging. Proven record as demonstrated working with global drug manufacturers in the pharmaceutical industry. Extensive background with tablets, liquids, ointments, creams, and aerosols. [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional with years of Project Management, Operations, Compliance, and Validation experience within major Pharmaceutical, Consumer Products and Biologics Manufacturers with demonstrated year-over-year improvements in quality, cost and delivery functions.  Broad experience as a strong, ethical, approachable, [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional with years of experience, skilled in analytical chemistry, quality control, quality assurance, quality systems, and regulatory affairs. Highly credentialed and experienced in medical device, drug, and fine chemicals manufacturing industries. Background in needle and infant [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Senior professional with technical, managerial, business process, and scientific knowledge, skilled in regulatory compliance, analytical development, product development, and quality control. Ph.D in Organic Chemistry with over 25 years of experience in the drug and combination [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional with over 20 years of experience in design engineering, project management, tooling engineering, plastics and polymer engineering, and manufacturing engineering. Highly credentialed with expertise in medical device and drug manufacturing industries. Background in drug delivery [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Consulting professional with over 30 years of management experience in packaging, labeling, change control, production engineering, purchasing, and operations. Technical and project management knowledge gained in working with top drug, cosmetic, medical device, and food manufacturers. [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com 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, [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Experienced Senior QA Manager with 20+ years in Quality Assurance and Quality Control in GxP in pharma, biotech, clinical trials, medical device, and Cell and gene Therapy industries. Skilled in ensuring compliance with regulatory standards, Quality [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Pharmaceutical Professional with over 20 years of solid technical and compliance knowledge in all aspects of manufacturing, cGMP compliance, regulatory compliance, validation, equipment validation ( including tablet presses and coaters, granulation equipment, liquid fillers, high shear [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Excellent track record of over 20 years effective implementation and maintenance of Quality Systems and compliance programs for ISO 13485, ISO 9001, ISO 17025, 21 CFR 820, 21 CFR 210, and 21 CFR 211. Various industries: [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Results-driven medical device professional with extensive background and experience in design controls, Risk Management, DHF preparation, audit, and remediation, project/program management, and product design/development for global medical device companies. Background in coated urological catheters, IV drug [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Effective leader with successful reputation for heading Quality System, Compliance, R&D, and Quality Operations organizations in global medical device businesses. Proven ability to develop, maintain and improve quality systems and processes, data governance, team building, collaboration [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com A seasoned quality and regulatory professional with over 30 years of technical and compliance experience in global Medical Devices/Diagnostics, Pharmaceuticals, Combination Products, Consumer Products, Dietary Supplements and Foods industries. Strong combination of Quality Systems, Compliance, Regulatory, [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional with solid technical background, skilled in product development, project management, and manufacturing engineering. Highly credentialed engineer with years of experience with top global medical device and drug manufacturers. Background in diagnostics, venous access safety related [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional with over 30 years of solid technical and compliance knowledge in manufacturing, operations, and technical management. Experience working in top global medical device, drug, biologics, and combination product manufacturing companies. Background in intraocular lenses, drug [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Biotechnology professional with operations and project management experience supporting biomaterials engineering projects and applications. Multidisciplinary education, research, product management and business development experience in multiple biomaterial groups (ceramics, metals, polymers, liquids) to answer medical needs in [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Problem-solving medical device and combination product engineer with extensive experience in systems engineering, change control, product development, post-launch support, project management, and leadership. Known for strong attention to detail, process optimization, organizational skills, and effective communication. [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional with solid compliance knowledge, skilled in quality management systems. Highly credentialed with years of experience with medical device and drug manufacturers. Background concentrated in in vitro diagnostics and sterile/reusable surgical medical device products. [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com A seasoned medical device quality system consultant with over two decades of experience in global quality systems and regulations. Expertise spans across medical devices from Class I to Class III, covering all parts of the product [...]

Director   (610) 462-4090   info@qualitysolutionsnow.com Professional with solid technical and compliance knowledge, skilled in product development, quality engineering, and regulatory affairs. Highly credentialed with years of experience in top global medical device, biologics, and drug manufacturers. Background in orthopedic implant, safety [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional consultant having executive experience, with expertise as lead or principle certified auditor responsible for audit planning, scheduling, conducting, and reporting for numerous ISO 9001, ISO 14001, ISO 13485, and OHSAS 18001 management systems. Highly credentialed [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Professional with solid technical and compliance knowledge, skilled in product development, plastics and mechanical engineering, R&D, and program management. Highly credentialed with years of experience in top global medical device manufacturers. Background in combination products, cardiology, [...]

Consultant   (610) 462-4090   info@qualitysolutionsnow.com Experienced medical device professional with an accomplished 25+ year career of designing, launching, producing and supporting medical devices globally.  Have taken several Class II systems from concept through market end of life for Fortune 500 medical [...]