Sr. Quality Systems/CAPA Engineer

The Opportunity The Senior Quality Systems Engineer assures products conform to quality standards and establishes compliance with the quality system. Responsibilities include maintaining a collaborative partnership with cross‑functional team members that facilitates organizational success and employing advanced quality assurance techniques with an in‑depth understanding of ISO 13485 and US 21 CFR 820 QSR. What You’ll Work On Assure compliance with corporate and divisional requirements regarding metrics reporting for Management Controls / Management Review and CAPA quality systems. Assure the collection, compiling, reporting and dissemination of key quality and compliance metrics/data are completed within the required timing. Complete trend analysis of data as appropriate to ensure proper actions can be determined or assessed. Perform and assure timely follow‑up activities in support of key quality and compliance metric/data goals and policy/procedural requirements. Develop and provide data and analysis in support of Management Controls / Management Review and CAPA Quality Systems. Identify and implement opportunities for continuous improvement. Identify opportunities to apply, continuously improve, and redefine quality systems and controls product‑related processes in accordance with applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc. Represent Quality Systems as required in support of cross‑functional projects. Assist in company preparations for hosting external audits and participate in external and internal audits. Assist management teams to ensure timely closure of audit observations. Lead non‑conformance investigation teams to identify root causes and effective CAPAs. Lead, coach, and mentor non‑exempt and entry‑level exempt personnel on quality principles and procedures. Function as part of risk assessment teams to identify product, quality system and compliance requirements. Function as part of special project teams to identify compliance gaps and develop and execute strategies to close gaps. Required Qualifications Bachelor’s degree in engineering or a technical field. Minimum 5 years of engineering experience and demonstrated use of quality tools/methodologies; knowledge of FDA 820, GMP, ISO 13485, and ISO 14971. Preferred Qualifications Project management and leadership skills, including the demonstrated ability to lead multi‑departmental project teams and resolve quality‑related issues. Internal and external audit experience. MS or higher degree in a technical discipline. Advanced computer skills, including statistical/data analysis and report writing skills. Medical device industry experience. ASQ CQE or CQA certification. Benefits Base pay: $90,000.00 – $180,000.00 (location may vary). Location: United States – Pleasanton, CA. Standard work shift; travel: 10% of the time. Job Details Job Family: Operations Quality. Division: HF Heart Failure. Equal Opportunity Employer Statement Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link – English: EEO is the Law link – Español: #J-18808-Ljbffr