Abbott Staff Development Quality 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.
The Development Quality Engineer assures new or modified 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 by protecting patient/user safety and meeting business needs.
Define and lead on-time completion of Design Control Deliverables
Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
Identify and drive opportunities to improve the quality system as it relates to design control deliverables including risk management
Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
Define and lead Risk Management activities from product Concept through Commercialization
Support and ensure product reliability and risk based statistical analysis
Drive best practices for design test and inspection method development, and lead method validation activities
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Support manufacturing process development & qualification for new product commercialization and product changes
Support and ensure internal & external audit responses
Support and ensure on time product re-certifications
Support and ensure on time completion of Corrective and Preventive Actions
Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
Support development, execution and analysis of biocompatibility and sterilization qualifications
Complete Document Change Request Reviews in a timely and objective manner
Mentor, develop and lead other team members.
Support all Company initiatives as identified by 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.
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Bachelor level degree in Engineering or Technical Field; advanced degree preferred
8+ years experience in related field, Medical Device industry experience preferred
Professional certification in the related work area such as CQE is preferrable
Previous Quality engineering experience and demonstrated use of Quality tools/methodologies including knowledge of Medical device regualtion such as FDA 21 CFR 820, EU etc.
Preferaable experience with Electro-mechanical product/system
Experience working in a broader enterprise/cross-division business unit model preferred.
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.
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