Senior Specialist Quality Assurance - (Supplier Quality)

Abbott (abbottcareers2 board); Des Plaines (IL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health coverage (HIP)

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is a global healthcare leader committed to advancing the quality and safety of diagnostics and medical devices. The Senior Specialist Quality Assurance (Supplier Quality) will lead supplier quality management, perform supplier assessments, monitor performance, and drive continuous improvement across Abbott Molecular Diagnostics Division in Des Plaines, IL.

This role requires deep knowledge of regulatory requirements, ISO 13485, and CAPA processes, with 5+ years in a regulated environment.

Qualifications

• Bachelor's degree in science, engineering, or related field or equivalent experience.
• 5+ years in quality/compliance within regulated environments (medical devices/diagnostics/pharma).
• Experience with supplier quality, CAPA, audits, and regulatory requirements.

Responsibilities

• Lead supplier quality management activities across the division.
• Perform supplier quality system assessments and monitor supplier performance.
• Drive CAPA and supplier corrective actions.
• Support audits, inspections, and supplier metrics and monitoring.
• Travel up to 25% domestically to support supplier management.

Skills

Quality Assurance

CAPA

Regulatory Knowledge

Problem Solving

Audits

Education

Bachelor's degree in science/engineering

Master's degree preferred

Tools

Audit software

Minitab/Stat software

Job 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.

Working at Abbott

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

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.

This 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.

What You'll Work On

Cross-functionally lead Supplier Quality Management process improvements which may include supplier change notifications, corrective action and preventive action (CAPA) activities, new product introduction support, quality audits, complaint investigations and supplier metrics and monitoring.

Independently work to resolve complex issues. analyze complex problems and identify their impact. establish probabilities. draw conclusions reflecting broad business needs. ensure compliance.

Work may require collaboration with other Division sites and/or other Abbott divisions.

Responsible for completing documentation in a timely manner and in accordance with business standards.

Travel up to 25% domestically to support supplier management and goals.

Understand and comply with applicable EHS policies, procedures, and guidelines.

Works under general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectives.

Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives.

Drives functional performance that ensures cross-functional standards and expectations are met.

Required Qualifications

• Bachelors preferably in science, engineering or a closely related discipline, or an equivalent combination of education and work experience.
• Minimum 5 years relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical devices, diagnostics, or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position.

Preferred Qualifications

• Masters degree preferred.
• Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with audits and inspections.
• Strong working knowledge of ISO 13485 and regulatory requirements for medical devices
• Knowledge of quality management techniques and the application and principles of quality engineering. Strong knowledge and application of concepts, practices, and procedures. Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors. Understanding of statistics.
• Demonstrated initiative and problem-solving skills and critical-thinking skills. Ability and aptitude to use various types of databases and other computer software. Ability to prioritize.
• Strong organizational and project management skills. Ability or aptitude to influence without direct authority.
• Certified Lead Auditor trained.