Senior Specialist Quality Assurance (Supplier Quality)

Regulatory Toolkit; Des Plaines (IL); Vor Ort; USD 78.000 - 156.000; Vollzeit

Benefits dieser Stelle

Free medical coverage

Retirement plan

Tuition reimbursement

FreeU education

Zusammenfassung

Abbott in Des Plaines, IL is seeking a Senior Specialist Quality Assurance (Supplier Quality) to support supplier selection, approval, and maintenance. You will assess supplier quality systems, monitor performance, and drive corrective actions and improvements to ensure compliance with quality standards.

The role requires leading cross-functional improvements, resolving complex issues, and travel up to 25% to support supplier management.

Qualifikationen

• Bachelor's degree in science, engineering or closely related discipline or equivalent experience.
• Minimum 5 years relevant experience in quality/compliance/engineering in regulated environments (medical devices, diagnostics, pharma).
• Masters degree preferred; knowledge of US and international QSRs, ISO 13485, and regulatory requirements.

Aufgaben

• Lead supplier quality management process improvements (CAPA, supplier change notifications, audits).
• Resolve complex issues; analyze problems and assess risks; ensure compliance.
• Collaborate with division sites and Abbott divisions as needed.
• Complete documentation in a timely manner per business standards.
• Travel up to 25% domestically to support supplier management and goals.
• Understand and comply with applicable EHS policies and guidelines.

Kenntnisse

Quality Assurance

CAPA

Ausbildung

Bachelor's degree in science or engineering

Master's degree preferred

Jobbeschreibung

JOB DESCRIPTION:

Senior Specialist Quality Assurance (Supplier Quality)

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
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.

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

• 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. analyse 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.

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.

$78,000.00 – $156,000.00

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

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

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