Abbott Staff CAPA Engineer in Sylmar, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are seeking an experienced, high caliber CAPA Staff Quality Assurance Engineer to assure products, processes, and quality records conform to quality standards and establish compliance with the quality system. This role will include responsibilities for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.
Impact this role will have on Abbott:
Define and lead on-time completion of Quality Assurance (QA) engineering deliverables.
Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.
Identify and influence key stakeholders to develop and maintain QA procedures, forms, and systems.
Define best practices, develop, and lead training for QA systems.
Influence and guide other team members with product review and analysis for QA activities.
Ensure database and record storage maintenance and integrity for QA systems.
Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
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.
Drive best practices for tracking and proactive identification of manufacturing related complaints in alignment with Abbott goals.
Proactively identify data storage needs and communicate plans clearly to prevent potential system issues.
Adept at staying current with organizational and industry information and routinely mentors/leads other members of the organization on quality assurance practices.
Lead Global CAPA team with training, CAPA oversight, and CAPA deliverables.
Proficient as expert representative for presenting QA System to internal and external auditors. Investigate and resolve system nonconformance’s and concerns (defined during internal and external audits).
Defines and leads completion of risk assessment, as related to QA systems.
Support all Abbott initiatives as identified by senior management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred)
8+ years technical experience
Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, and ISO 13485
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.
Preferred qualifications and education:
Prior medical device experience preferred
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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com