Hiring.Camp

Senior Project Lead Quality Assurance - Columbus, OH

Abbott

·

Yesterday

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Salary
$78k – $156k
Location
United States > Columbus : 2900 Easton Square Place, United States of America
Workplace
Onsite
Type
Full-time
Department
IT
Seniority
Lead
Source
Workday

Description

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 122,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

 

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. You’ll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical 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 bachelor’s 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

Abbott is seeking a Senior Project Lead Quality Assurance to support its global complaint-management quality system. This position serves as a division-level subject matter expert, providing oversight of complaint procedures, training, data trending, regulatory compliance, and process improvement.

 

The role partners with regional and cross-functional teams to ensure product complaints are consistently registered, evaluated, investigated, trended, escalated, and closed. It reports to the Regional Complaint Manager - Americas.

 

 

 

What You’ll Do  

  • Serve as a subject matter expert for the global complaint-management quality system.
  • Maintain division complaint-management procedures, governance documents, and training materials.
  • Provide technical guidance to teams that register, evaluate, investigate, process, and close complaints.
  • Analyze complaint data to identify trends, emerging quality signals, compliance risks, and improvement opportunities.
  • Create and review quality records, complaint-trending decisions, and related corrective and preventive action activities.
  • Prepare complaint metrics and reports for quality leadership and cross-functional stakeholders.
  • Lead quality-system improvement projects from problem definition through implementation and effectiveness monitoring.
  • Support internal audits, certification audits, and regulatory inspections.
  • Register complaints received from U.S. government agencies, as needed.
  • Escalate significant product-quality or compliance risks through appropriate quality-system channels.

 

Required Qualifications

  • Bachelor’s Degree or appropriate job experience (16+ years), preferably in engineering, life sciences, food science, regulatory affairs, or a related discipline.
  • At least three years of experience in quality assurance, quality systems, complaint handling, post-market monitoring, or a related discipline.
  • Experience interpreting and applying procedures or regulatory requirements in a regulated environment.
  • Experience analyzing quality data and communicating trends, risks, and recommendations.
  • Demonstrated ability to lead or contribute to cross-functional improvement projects.
  • Strong written, verbal, organizational, and stakeholder-management skills.
  • Ability to manage competing priorities and work effectively with geographically dispersed teams.

 

 

Preferred Qualifications

  • Experience with complaint management, post-market surveillance, or product-quality trending.
  • Experience in the nutrition, food, pharmaceutical, medical-device, consumer-health, or another FDA-regulated industry.
  • Experience with electronic quality-management systems and quality-data reporting tools.
  • Experience supporting audits or regulatory inspections.
  • Project-management, Lean, or Six Sigma training or certification.
  • Experience working with teams across multiple regions or time zones.

 

Additional Information:

This position is on-site in Columbus, Ohio. A remote option is not available. Relocation assistance is also not available. Occasional meetings outside standard local business hours are required to support global teams. Travel is not required.


Apply Now

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 and @AbbottGlobal.

     

The base pay for this position is

$78,000.00 – $156,000.00

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ANSC Nutrition Supply Chain

        

LOCATION:

United States > Columbus : 2900 Easton Square Place

     

ADDITIONAL LOCATIONS:

     

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)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Skills

FDAComplianceSix Sigma

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