Quality Engineer III

At Abbott you can do work that matters grow and learn care for yourself and family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity working mothers female executives and scientists.

The Opportunity

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. Were 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 webbased 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 Youll 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 customerfacing 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 softwarebased systems including SaMD digital health solutions or regulated web platforms.

• Experience collaborating crossfunctionally with R&D IT Regulatory Marketing and external partners to enable compliant deployment of digital solutions.

• Ability to provide quality oversight of thirdparty 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 crossfunctional and audit settings.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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