Product Quality Engineer - LINGO

Product Quality 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 Product Quality Engineer analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.

What You’ll Work On

• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Apply clinical and/or technical knowledge, as related to product application, to evaluate identified complaints.
• Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
• Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Apply codes to events to facilitate product performance records.
• Review coding and investigations with engineering, laboratory, and other internal staff.
• Compose written communications detailing the clinical and/or observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
• Communications include determination/eligibility for warranty credit or unreimbursed medical payments.
• Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks.
• May demonstrate basic project management skills by acting as a project lead on small, well-defined projects.
• Provides guidance to less experienced staff.
• Influence exerted at peer level and occasionally at first levels of management.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.
• Exercises authority and judgment within defined limits to determine appropriate action.
• Failure to achieve results or erroneous decisions or recommendations may cause delays and may result in the allocation of additional resources.

Required Qualifications

• Bachelor’s Degree combined with 2-5 years of related work experience with a good understanding of specified functional area.
• Working knowledge and application of business concepts, procedures and practices.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment.

* 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 $65,900.00 – $131,900.00. In specific locations, the pay range may vary from the range posted.

• product application
• quality system performance
• project management
• good manufacturing practices
• gmp compliance management
• quality system
• lingo technology development
• product analysis
• business operations
• schedule management
• new biosensing technology
• lingo