Quality Systems Analyst II

JOB DESCRIPTION:

Quality Systems Analyst II

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 Systems Analyst II will be responsible for supporting trend escalations ensuring that potential product or process issues are thoroughly assessed and effectively managed. This includes applying structured root cause analysis (RCA) methodologies such as 5 Whys Fishbone diagrams and 6M frameworks to identify underlying drivers validate findings and reach well-supported conclusions for investigations.

This position will be based out of our Abbott Diabetes Care in Alameda CA and the individual will be expected to be onsite Monday-Friday.

What Youll Work On

• Support complaint investigation activities related to glucose meters ensuring compliance with procedures and timely completion.
• Partner with cross-functional Quality and Business Unit teams to deliver required reporting including but not limited to:
  • Complaints trending and summaries
  • FDA Medical Device Reporting (MDR) trending and summaries
  • EU Medical Device Vigilance trending and summaries
  • Weekly monthly and quarterly product line complaint reports
• Prepare and provide relevant reports and analysis in support of internal and external audits.
• Support company initiatives aligned with the Quality Management System (QMS) Environmental Management System (EMS) and other regulatory requirements.
• Ensure compliance with FDA regulations international regulatory requirements and corporate/divisional policies procedures and processes.
• Perform additional related duties and responsibilities as assigned.

Required Qualifications

• Bachelors degree required.
• Minimum 3 years of experience in a manufacturing environment; medical device industry experience preferred.
• Experience conducting complaint investigations in a regulated environment.
• Knowledge of FDA Quality System Regulations (QSR) and ISO 13485 standards.

Preferred Qualifications

• Strong ability to manage multiple tasks and priorities in a fast-paced changing environment.
• Advanced proficiency with Microsoft Office; experience with SQL is a plus.
• Strong analytical skills with the ability to query refine and summarize data.
• Excellent communication skills with the ability to interact effectively across multiple functions (Customer Support R&D Manufacturing) and at various levels of the organization.
• Proven ability to work collaboratively within a team and independently as an individual contributor.
• Strong organizational skills attention to detail and ability to meet deadlines.
• Demonstrated ability to leverage and engage others to accomplish projects.

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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Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 people with diabetes from routine fingersticks.

Diabetes

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.

The base pay for this position is

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

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