Job Details

Abbott Diabetes Care Position

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 115,000 colleagues serve people in more than 160 countries.

This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

This position is responsible for activities related to design control, qualification, specification, and corrective and preventive action (CAPA) of medical devices, including software as a medical device (SaMD), digital platforms, and globally deployed web-based systems supporting regulated products. The role will have a particular emphasis on governance, design control, and quality oversight of worldwide website unification initiatives, ensuring consistent compliance, risk management, and lifecycle documentation across regions.

What You'll Work On

• Drives alignment in cross functional meetings acting as QA representative on new and on market product design projects to ensure compliance with the design control process.
• Reviews and approves engineering changes in a timely manner
• Collaborates with R&D and Marketing to support mobile app deployment activities (for Software as a Medical Device projects)
• Drives alignment during cross functional review and approval of impact assessments, root-cause analysis investigation and resolution activities
• Reviews and approves batch records for products used in design verification/validation testing and clinical investigations
• Ensures Device History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures
• Collects, organizes, and monitors information related to quality and process improvement
• Participates in internal & external audits and ensures audit responses are submitted in a timely manner
• Leads/supports design planning efforts to include heading CFTs; establishing deliverables and tracking completion for complex projects.
• Leads/supports complex investigations and CAPA activities.

Required Qualifications

• Bachelors degree in Engineering, Science, or technical related field
• Minimum 5 years applicable technical/engineering experience and demonstrated use of Quality tools/methodologies.
• Minimum 3 years regulated industry and preferable experience with design control and software as medical device.

Preferred Qualifications

• Experience supporting global, customer-facing websites or digital platforms within a regulated environment, including governance of content, configuration, and release management across regions.
• Working knowledge of web technologies (HTML, CSS, JavaScript) and common content management systems or web platforms.
• Experience applying design control principles to software-based systems, including SaMD, digital health solutions, or regulated web platforms.
• Experience collaborating cross-functionally with R&D, IT, Regulatory, Marketing, and external partners to enable compliant deployment of digital solutions.
• Ability to provide quality oversight of third-party or outsourced software development, including review of design documentation, validation evidence, change controls, and supplier deliverables.
• Ability to operate effectively in global organizations, influencing without direct authority and balancing regional and global quality needs.
• Strong written and verbal communication skills, with experience reviewing, approving, and defending quality and design documentation in cross-functional and audit settings.

The base pay for this position is $100,000.00 $200,000.00. In specific locations, the pay range may vary from the range posted.