Abbott · 3 hours ago
Sr. Hardware Design Quality Engineer
United States - California - San Diego
Full-time
Onsite
Senior Level
$90K/yr - $180K/yr
5+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Design Quality Engineer will participate in product development and transfer activities, ensuring product and process conformance to FDA and ISO 13485 standards, while also providing training to other engineers and quality assurance personnel.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
Represent the Quality function to provide design assurance support in the design and development of medical device products and facilitate the application of design controls and risk management
Providing training and guidance to other Design Quality Engineers and Quality Assurance professionals on new product development and change processes
Act as a reviewer and approver of validation methods and protocols, test methods, statistical analysis methods and specification development
Review new and modified product designs for quality. Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and other global regulations
Act as a key contributor to development and validation plans and processes
Act as a key team member in establishing, communicating and mitigating risks
Ensure successful transfer of new products to manufacturing
Review design history files and technical files for conformance to applicable requirements
Support the continuous improvement to the Quality Management System, with a specialty focus on design controls and associated processes
Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance
Provides leadership in all areas of the Quality System, including but not limited to design controls, risk management, etc
Provides leadership in the understanding of FDA and applicable non-US regulations pertaining to medical or pharmaceutical manufacturing, including hardware, software, and bioassay systems
Qualification
Required
Bachelors' degree (B.S.) in a Science related field, or equivalent combination of education and experience
5+ years related experience and/or training in a Quality and/or Development Position
Significant experience in risk management throughout the product lifecycle, including a strong working knowledge of ISO 14971
Preferred
Experience supporting ISO 13485 inspections and FDA inspections
Working knowledge of quality techniques such as root cause analysis, 5 why's, and Ishikawa diagrams
Experience in a multi-site development environment
Experience in compliance management within a rapid-growth, dynamic organization
Benefits
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
2026-01-07
Company data provided by crunchbase