JOB DESCRIPTION:The OpportunityAbbott 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 NowLearn 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.
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)
