Senior Supplier Quality Assurance Engineer

Job Title Sr. Quality Specialist – Post Market & Supplier Quality Opportunity This role independently leads projects to resolve complex issues by analyzing problems, assessing risks, and drawing conclusions aligned with business and compliance needs. It involves reviewing complaints for regulatory compliance and patient safety impact, determining reportability, and preparing regulatory submissions such as MDRs and vigilance reports. The position also manages supplier quality processes, including onboarding, risk assessment, and ensuring adherence to global standards such as ISO 13485 and FDA regulations. Additionally, it drives cross‑functional collaboration and quality system improvements across areas such as CAPA, audits, validation, and post‑market surveillance. The role requires strong decision‑making, timely documentation, and the ability to balance business objectives with risk mitigation, while occasionally traveling and ensuring adherence to EHS and organizational policies. Responsibilities Independently lead groups and projects to resolve complex issues, analyze complex problems and identify their impact, establish probabilities, and draw conclusions reflecting broad business needs while ensuring compliance. Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations. Establish regulatory reportability decisions using event investigation and regulatory decision models. Own supplier onboarding, qualification, and requalification processes, including supplier risk assessments, quality agreements, documentation review, and Approved Supplier List maintenance. Lead supplier quality assurance activities to ensure compliance with internal quality standards and applicable regulations, including ISO 13485, FDA QSR, MDR/IVDR, and other global requirements. Write Medical Device Reports, MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities. Compose written communications detailing clinical observations, investigations, and corrective actions to end‑use customers or regulatory bodies. Cross‑functionally lead alignment between departments and/or divisions which may include complaint handling, customer service, medical events, and product quality. Lead cross‑functional quality system process improvements such as training, CAPA activities, equipment maintenance, product and process planning, quality audits, validation, product development/clinical research, design control activities, complaints, and post‑market surveillance. Work may require collaboration with other Abbott divisions. Responsible for completing documentation in a timely manner and in accordance with business standards. Travel up to 10% of the time domestically and internationally. Understand and comply with applicable EHS policies, procedures and guidelines. Work under general direction; independently develop approach to solutions; work is reviewed upon completion for adequacy in meeting objectives. Make timely and effective decisions related to business issues within scope of responsibility; appropriately elevate high‑risk issues; recommend appropriate action to achieve departmental objectives. Drive functional performance that ensures cross‑functional standards and expectations are met. Qualifications Bachelor’s Degree or equivalent combination of education and experience. 5 years relevant experience in Quality, Compliance, Engineering, or similar roles within a regulated environment such as medical device, diagnostics, or pharmaceutical industries. Knowledge of applicable U.S. and non‑U.S. quality system requirements and other relevant regulations for medical devices; prior experience with regulatory bodies. Knowledge of software regulations and compliance (21 CFR Part 11). Knowledge of ISO 13485; knowledge of consumer regulations is a bonus. Proficiency in quality management techniques and quality engineering principles; strong understanding of statistics. Strong interpersonal and professional relationship skills; displays socially and professionally appropriate behavior. Ability to work independently and in groups, including cross‑functional teams. Demonstrated initiative, problem‑solving, and critical‑thinking skills. Proficiency using various types of databases and other computer software. Strong organizational and project management skills; ability to prioritize. Ability to lead without direct authority. Compensation The base pay for this position is $90,000.00 – $180,000.00. Salary may vary by specific location. EEO Statement Abbott is an Equal Opportunity Employer, committed to employee diversity. #J-18808-Ljbffr Abbott Laboratories