Abbott Senior Quality 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 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. Provide quality assurance (QA) and quality engineering (QE) support to respective Product Line(s). Serves as a subject matter expert on the requirements and processes that result in the integration of the voice of the customer into the design and realization of products. Provides ownership for successful integration of appropriate Risk Management considerations into both design controls and issue resolution. Monitors field product performance for emerging trends and improvement opportunities for application to new product designs.
Leads and participates in new product development process by ensuring that all the quality data streams are fully comprehended and that the voice of the customer, as heard through these data streams (complaints, non-conforming records [NCRs], verified failures, etc.), is a design input and consideration.
Define and lead on-time completion of Design Control Deliverables.
Provide subject matter expertise and ownership for Risk Management activities, including, the comprehensive and accurate assessment and characterization of design risks, which includes both the appropriate mitigation activities and proper identification in downstream design outputs (design failure modes and effects analysis [DFMEA], Critical To Quality and Critical To Process characteristics on specifications, Risk Assessments for issues impacting distributed product, etc.).
Represent the QA/QE function for the review and approval of designated design outputs
Lead and support all activities as required to ensure successful transfer of design to manufacturing and responsible for transfer to sustaining engineering.
Create and ensure on-time execution of Quality Plans for internal development, OEM-based 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
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 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
Accountable for 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.
Additional duties may be identified by functional management based on the current project/business objectives.
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
Bachelor’s degree in Mechanical, Electrical, Software Engineering or Computer Science. MS or higher degree in a technical discipline
Advanced computer skills, including statistical/data analysis and report writing skills
medical device experience
ASQ CQE SQE or other certifications
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