Quality Assurance Engineer II

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.

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. You'll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical 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 bachelor's 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. We're 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 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 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 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 Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.

abbottbenefits.com 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. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $90,000.00

• $180,000.

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

JOB FAMILY

Operations Quality

DIVISION

ADC Diabetes Care

LOCATION

United States >

Alameda :

2901 Harbor Bay Parkway

ADDITIONAL LOCATIONS

WORK SHIFT:

Standard TRAVEL:

No

MEDICAL SURVEILLANCE

Not Applicable

SIGNIFICANT WORK ACTIVITIES

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link

• English:

  http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link

•

Espanol:

http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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