Product Quality Engineer - LINGO
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Locations: United States - California - Alameda
Time Type: Full time
Posted on: Posted 30+ Days Ago
Job Requisition ID: 31089383
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:
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.
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.
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.
JOB FAMILY:
Operations Quality
DIVISION:
LNGO Lingo
LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
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)
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