Senior Design Quality Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

bout Abbott

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott's life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations - with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

The position of Senior Design Quality Engineer is available with Ionian Technologies, a subsidiary of Abbott, at our location in Carlsbad, CA.

In this role you will actively participate in product development and transfer activities, ensuring product and process conformance to FDA and ISO 13485 standards. This position will review validation methods and protocols, test methods, statistical analysis methods and specification derivation and assignment. Review new and modified product designs for quality characteristics, including manufacturability, serviceability, and conformance to product requirements. The position is responsible for training other Design Quality Engineers and Quality Assurance personnel in Design Controls and Risk Management. This role requires strong communication, interpersonal and organizational skills, and a solid understanding of the application of FDA, ISO 13485, and ISO 14971 standards.

If you seek a dynamic role where your contributions will pave the way in developing new products, systems, and processes, come work with us!

WHAT YOU'LL DO

• 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 with software and hardware development.
• 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.

EDUCATION AND EXPERIENCE YOU'LL BRING

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 21 CFR 820.30, ISO 14971, IEC 62304 and cybersecurity.

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.

COMPETENCIES:

• Communicates effectively at all levels within Quality as well as cross-functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing
• Excellent problem solving and decision-making skills.
• Initiative to work towards goals with minimal supervision

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority (Manufacturing roles only)
• Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only)
• 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

Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.