Abbott Staff Quality Engineer in Santa Clara, 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.
Provide Process/Quality Engineering support to R&D/Operations/Manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
Leads Incoming Receiving Inspection (scrap, nonconforming material, follow up with suppliers, inventory control). Develops and implements product specifications, quality specifications, quality plans, risk analyses, FMEAs, MPI, LHRs, STMs, in conjunction with other product development team members. Provides quality assurance and quality engineering support to product development teams for drawings, material specifications, engineering reports and protocols, design verification and validation activities. Supports, reviews and approves Document Change Orders. Supports R&D product builds in the cleanroom for bench testing, animal lab, and first in human activities. Develop, review, and approve rework instructions, in process inspections, and final product inspections. Support cleanroom certification and validation activities. Creates Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, by identifying & implementing more effective tools & materials, and by communicating new tools/materials to respective teams.
(Influence/Leadership) Understands business environment and relates extensive knowledge of internal and external technological activities to trends. Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. Participates in the development of other technical contributors by facilitating training and providing feedback and guidance. May lead a project team. Provides technical leadership to business units. Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees. Exercises judgment independently.
(Planning/Organization) Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones. Establishes priorities of individual or project assignments.;
(Decision Making/Impact) Selects methods and techniques to lead a project to completion. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.
Experience with the following:
ISO 13485:2012 Medical Devices – Quality Management System
21 CFR Part 820 FDA Quality System Regulations
ISO 14971 Medical Devices – Application of Risk Management
Good Manufacturing Practices And Good Documentation Practices
Bachelor's degree plus 9+ years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.
Business Knowledge (Job Skills))
Comprehensive knowledge of a particular technological field. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
(Cognitive Skills) Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business.
OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL
NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.
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 firstname.lastname@example.org