Sr. Quality Specialist – Post Market & Supplier Quality

Abbott • Alameda, CA

14h • Onsite

About The Position

This Sr. Quality Specialist – Post Market & Supplier Quality 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 like 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.

Requirements

• Bachelor’s Degree or an equivalent combination of education and experience.
• 5 years relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical device, diagnostics, or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position.
• Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices.
• Previous experience with regulatory body.
• Knowledge of software regulations and compliance (21 CFR Part 11).
• Knowledge of ISO 13485.
• Knowledge of quality management techniques and the application and principles of quality engineering.
• Strong knowledge and application of concepts, practices and procedures.
• Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
• Understanding of statistics.
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.
• Ability to work independently and in groups; ability to work cross-functionally.
• Demonstrated initiative and problem-solving skills and critical-thinking skills.
• Ability and aptitude to use various types of databases and other computer software.
• Ability to prioritize.
• Strong organizational and project management skills.
• Ability or aptitude to lead without direct authority.

Nice To Haves

• knowledge of consumer regulations a bonus.

Responsibilities

• Independently lead groups and projects to resolve complex issues.
• Analyze complex problems and identify their impact.
• Establish probabilities.
• Draw conclusions reflecting broad business needs.
• Ensure 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 (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, 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.
• Cross-functionally lead Quality System process improvements which may include training, corrective action and preventive action (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 Division sites and/or other Abbott divisions.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Travel up to 10% of the time both domestically and internationally to support organizational goals.
• Understand and comply with applicable EHS policies, procedures and guidelines.
• Works under general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectives.
• Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives.
• Drives functional performance that ensures cross-functional standards and expectations are met.

Benefits

• free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior