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Driven Quality Engineer with over 5 years of experience in Medical Devices Quality, Regulatory, and Risk Management. Proven record of driving continuous improvement initiatives, change management, and auditing regulatory processes. Reliable and collaborative team player with an ability to handle multiple projects simultaneously with a high degree of accuracy.

A strong Quality Assurance & Document Control Manager Professional with dedication to Pharma, Bio tech, and Medical Device companies; focused on new product development and technical projects, promoting high-quality standards to deliverables, and ensuring client satisfaction to completion. Strategic oversight, driving the success through managing projects, compliance & quality, CAPA, regulatory, technical writing, IT application/systems, document management and control, user training combined with 20-plus years of resilient self-driven abilities.

Results-driven and detail-oriented Quality Assurance professional with over 20 years of experience in the pharmaceutical industry. Well-versed in good manufacturing practices and knowledgeable about Canadian cGMP and FDA requirements. Demonstrated exceptional communication, self-motivation, and target-oriented skills while performing all duties and responsibilities. Thrived in a fast-paced environment, exhibiting strong interpersonal and leadership abilities, and excelled with minimal supervision. Proficient in various computer software programs, including MS Word, Excel, Outlook Web, ERP, and SAP. Skilled in documentation management, including electronic Quality Management Systems. Recognized for maintaining high standards and achieving consistent results. Proven track record of identifying and resolving quality issues to uphold top-tier product standards. A reliable team player focused on collaboration and adapting to evolving project needs. Expertise in quality control processes and meticulous analysis.

Highly experienced professional specializing in supplier quality management and development within the pharmaceutical and medical device industries. Provides quality support for clinical/commercial research GMP-related materials, including single-use supplies, equipment API, raw materials, and chemicals. Qualifications include conducting risk-based supplier quality audits, coordinating with suppliers for material and process validation, and reviewing documentation for accuracy, legibility, traceability, and consistency. Manages supplier change notifications, maintains approved supplier/vendor lists (ASL) and new supplier approval processes. Handles corrective action requests (SCAR), supplier performance evaluations, and the creation/revision of quality agreements. Skilled in monitoring risk, reviewing raw materials specifications (RMS), addressing critical quality issues, deviations, non-conforming materials, and conducting root cause analysis. Manages change control, CAPA management, complaints & recalls and actively supports continuous improvement and problem-solving initiatives,

Sarah Lindenblad

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Quality Assurance Specialist

Quality Systems Manager

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Bachelor's Degree - Studio Art/Graphic Design

Bachelor's Degree - Anthropology

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Quality Assurance Specialist

Quality Systems Manager

Florida State University

Florida State University

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