JOB DESCRIPTION:The OpportunityThis position works out of our
Des Plaines, IL location in the
Abbott Molecular, Diagnostics Division. We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.
The
Senior Specialist Quality Assurance - Supplier Quality will support in the selection, approval, and maintenance of the division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities.
What You'll Work On- Independently conducts and leads audits across supplier and TPM network.
- Maintain and strengthen Quality System effectiveness by ensuring adherence to regulatory requirements, site procedures, and corporate quality policies.
- Provides guidance and trains colleagues, provides mentoring to one or more junior level auditors.
- Participates as SME in audits, provides compliance, and strategic solutions to complex quality issues.
- May lead projects that are cross-functional in scope, directly influence project direction and scope, champions new initiatives and acts as the catalyst for change.
- Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies.
- May assume managerial responsibilities as needed.
- May mentor less senior level members of the group
- Develop innovative, compliant, and practical solutions to complex quality challenges that support organizational goals and operational excellence.
- Communicate effectively with management, suppliers, and cross-functional partners to drive project direction, quality strategy, and business results.
Required Qualifications- Bachelors Degree
- Minimum 7 years in Quality or related field experience; Less experience may be appropriate with advanced degree.
Preferred Qualifications- Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body. Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; ISO 13485; IVDD; etc.
- Certified ISO Lead Auditor qualification or equivalent is required. Excellent written and verbal communication skills.
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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 $86,700.00 - $173,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:AMD Molecular
LOCATION:United States > Des Plaines : DP01
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 25 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
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), Work requiring repeated bending, stooping, squatting or kneeling
