Senior Specialist Quality Assurance (Supplier Quality)

United States - Illinois - Des Plainessenior

OtherQuality Assurance

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Quick Summary

Overview

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,

Technical Tools

OtherQuality Assurance

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 115,000 colleagues serve people in more than 160 countries.

Senior Specialist Quality Assurance (Supplier Quality)

What We Offer

~1 min read

✓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.

Requirements

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Bachelor's 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.

Master's 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.

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Operations Quality

AMD Molecular

United States > Des Plaines : DP01

Standard

Yes, 25 % of the Time

Not Applicable

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