Sr. Quality Systems Engineer - LINGO

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Sr. Quality Systems Engineer - LINGO

Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health.

The Opportunity

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.

The Sr. Quality Systems Engineer will be responsible for implementing and progressively improving the CAPA process and electronic system within the Quality Management System at Lingo.

What You’ll Work On

• Lead the Corrective Action and Corrective Action program at Lingo in line with all site and corporate requirements.
• Own Nonconformance and CAPAs, as well as coordinate the completion of these deliverables owned by others in Lingo.
• Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.
• Provide guidance, insight and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements.
• Lead and/or contribute to continuous improvement initiatives and projects.
• Provide subject matter expertise during audits and inspections.
• Represent CAPA QA in cross functional meetings (site and division).
• High proficiency leading meetings and communications for QA system information, concerns, and updates.
• Lead, develop, and mentor others with QA data analysis, trending, and reporting. High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.
• Adept at staying current with organizational and industry information and routinely mentors/leads other members of the organization on quality assurance practices.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Travel: 10% (domestic).

Required Qualifications

• Bachelor’s Degree, preferably in Engineering, Technical Field, Life Science, or closely related discipline.
• 5+ years’ experience in Quality or related field experience.
• 2+ years’ experience with CAPA and/or Quality Assurance/engineering experience and demonstrated use of quality tools/methodologies.

Preferred Qualifications

• Experience working with software and/or software as a medical device (SAMD).
• Certified Quality Engineer (CQE) from ASQ.

* 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:  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

$95,500.00 – $190,900.00

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

LNGO Lingo

        

LOCATION:

United States > Alameda : 2901 Harbor Bay Parkway

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE: