Abbott Sr Quality System Engineer in Pleasanton, 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.
The Senior Quality Systems Engineer assures products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success. The position employs an individual skilled in advance quality assurance techniques with an in-depth understanding of the ISO 13485 Quality Standard and US 21 CFR 820 QSR. Areas of focus will include improving quality system infrastructure, performance metrics and ISO, FDA and GMP compliance.
Assure compliance with corporate and divisional requirements regarding metrics reporting for the 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 requiring 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
Participate in external and internal audits
Assists 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.
Bachelor’s degree in Engineering or Technical Field
Minimum 5 or more years of Engineering experience and demonstrated use of Quality tools/methodologies
knowledge of FDA820, GMP, ISO 13485, and ISO 14971
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
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