Senior Specialist Quality Assurance - Supplier Quality
Abbott
Summary
This position works out of our Des Plaines, IL location in the Abbott Molecular, Diagnostics Division. 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.
Job description
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.
Requirements
- Bachelors Degree
- Minimum 7 years in Quality or related field experience; Less experience may be appropriate with advanced degree.
- 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.
Benefits
- Medical coverage
- Retirement savings plan
- Tuition reimbursement
- Student debt program
- Education benefit
Company overview
Abbott Laboratories is a global healthcare leader with a 135-year legacy of innovation, dedicated to helping people live healthier, fuller lives through life-changing technologies and products. Headquartered in Abbott Park, Illinois, the company operates in more than 160 countries with a workforce of approximately 114,000 professionals. Abbott's diversified portfolio spans four core business segments: medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals. The company is particularly renowned for its groundbreaking medical devices including cardiovascular technologies, diabetes management systems like the FreeStyle Libre continuous glucose monitor, neuromodulation devices for chronic pain, and the AVEIR DR dual chamber leadless pacemaker system. In diagnostics, Abbott has been instrumental in developing critical tests, including the first licensed HIV test in 1985 that helped secure blood supply safety. The company's nutrition division produces leading infant formulas like Similac, while its pharmaceutical business provides quality branded generic medicines. Abbott consistently ranks among Fortune's Most Admired Companies and maintains a strong commitment to sustainability and corporate responsibility, making it a trusted partner in advancing global healthcare.