Quality Assurance Manager

Quality Assurance Manager (Bogdanoff) Working at Abbott

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. You’ll 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 bachelor’s 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.

As a Quality Assurance Manager for Complaint Investigations, they will be responsible for sustaining the complaint investigation operation, while developing a team and leading projects to advance the lab for future expectations with regards to compliance, capabilities, and workforce output. This role oversees engineers and leads for direct and indirect labor to sustain complaint investigations, and complaint returns. This role is responsible for establishing an operation that performs consistently to maintain requirements for investigation timeliness, and develop processes for new or updated products, while ensuring ongoing compliance and audit readiness per Abbott's Quality Policies and Global Regulations.

• Oversee complaint investigation lab output and proficiency by developing strong teams and metrics to foster environment
• of continuous improvement
• Develop and maintain engineering team to advance investigation techniques for execution by direct labor workforce
• Support CAPA initiatives and ongoing projects to ensure ongoing proficiency in complaint investigations operation
• Represent Complaint Investigations lab for audits, projects, and generally acting as subject matter expert for complaint investigations processes.
• Develop metrics and presentations for Quality System Management reviews and associated requirements to ensure compliance and maintain performance
• Reviews and provides functional approval for project and quality system documentation
• Develops and implements plans, ensures milestones are met and prioritizes resource workload as required to meet commitments
• Measures and reports performance of personnel and process relative to targets

• Bachelor’s degree or an equivalent combination of education and work experience.
• Minimum 7 years of experience in a FDA/ISO regulated environment.
• Minimum 5 years of experience in Quality.

• Substantial demonstrated initiative and problem-solving skills; critical-thinking skills.
• Experience in leading & managing a large team of people.
• Experience working in process and test method development in a Quality management system, in collaborations with Quality Assurance/ with Operations and R&D

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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Medical Devices

General Medical Devices:
Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

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.

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