Quality Assurance Engineer II

JOB DESCRIPTION:

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and your 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.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity working mothers female executives and scientists.

The Opportunity

The Quality Assurance Engineer II position works out of our Alameda CA location in the Diabetes Care Division. Were 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 preventative action of medical devices including software as a medica device (SaMD) in-vitro diagnostic devices consumer devices and accessories. Lead/support design planning efforts to include heading CFTs; establishing deliverables and tracking completion for complex projects. Support complex investigations and CAPA activities.

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

Required Qualifications

• BS in engineering or related field (Mechanical or Biomedical preferred)
• 3 years of Quality experience ideally within Design Controls - Design for Manufacturability
• Prior Medical Device industry experience
• Statistical Analysis experience - Nice to have
• Calibration/Preventative Maintenance experience - Nice to have

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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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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