Staff CAPA Engineer

We are seeking an experienced, high caliber CAPA Staff Quality Assurance Engineer. Responsible for implementing and progressively improving the CAPA process and electronic system within the Quality Management System at Abbott. Reports to the Regulatory Compliance Manager for the Cardiac Rhythm Management business unit. Responsibilities: Lead, mentor and motivate a team of Quality Engineers Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues Accountable for leadership and oversight of the CAPA system, and associated deliverables Provide guidance, insight and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements. Lead and/or contribute to continuous improvement initiatives and projects Provide subject matter expertise during audits and inspections Represent CAPA QA in cross functional meetings (site and division) High proficiency leading meetings and communications for QA system information, concerns, and updates. Lead, develop, and mentor others with QA data analysis, trending, and reporting.  High proficiency with reporting and publishing weekly, monthly, and quarterly metrics. Adept at staying current with organizational and industry information and routinely mentors/leads other members of the organization on quality assurance practices. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Performs other related duties and responsibilities, on occasion, as assigned. Education/Experience: Bachelor level degree in Engineering, Technical Field, Life Science or closely related discipline is required (advanced degree preferred) OR relevant combination of education and experience At least 8 years work experience in Quality or related field experience Preferred Qualifications/Skills: Previous CAPA and/or Quality Assurance/engineering experience and demonstrated use of quality tools/methodologies Prior medical device experience preferred Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016 Solid communication and interpersonal skills Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner Advanced computer skills, including statistical/data analysis and report writing skills Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 20%, including internationally. Ability to maintain regular and predictable attendance. ASQ CQT, CQE, CQA certification preferred Six Sigma root cause analysis/problem solving training and experience preferred. Experience working in a broader enterprise/cross-division business unit model preferred. 30907863
Salary Range: NA
Minimum Qualification
5 - 7 years

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