Supplier Quality Engineer

at  Abbott Laboratories

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 114,000 colleagues serve people in more than 160 countries.

MAIN PURPOSE OF ROLE

Responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers.
Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner.

MAIN RESPONSIBILITIES

• Supplier Audits Develop and execute to a supplier audit schedule per current requirements.
• Develop audit plans and associated supplier communications.
• Approve and monitor Supplier CAPA plans and activities to closure including objective evidence of effectiveness.
• ISO lead auditor certification or equivalent is preferred.
• Qualify and then monitor supplier performance Per current requirements perform activities that will qualify new suppliers

and monitor current supplier base to ensure the status of the suppliers is correct.

• Work with suppliers as needed to ensure their performance is acceptable per site requirements.
• Work with Design and Development, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier

performance.

• CAPA Through the supplier audits and internal issues with supplier product, issue SCARs for supplier corrective/preventive

action activities.

• Analyze Supplier information and present supplier metrics to appropriate CAPA boards.
• Demonstrated writing and communication skills are required for this position.
• A thorough understanding of the ISO/QSRs and the ability to apply that knowledge with an understanding of business

operations to achieve regulatory compliance is needed.

• Must be able to explain audit results and influence other’s understandings of audit observations in a tactful and

professional manner.

• Knowledge of regulations and standards affecting in vitro diagnostic’s device manufacturing.

Supervisory / Management Responsibilities
(Supervision Received) Works under general supervision. Follows established procedures. Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.;
(Supervision Provided) May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.
Position Accountability / Scope
(Influence/Leadership) Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion
of tasks. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors.
Influence exerted at peer level and occasionally at first levels of management.;
(Planning/Organization) Plans, organizes, and prioritizes own daily work routine to meet established schedule.;
(Decision Making/Impact) Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may
cause delays in program schedules and may result in the allocation of additional resources.
Minimum Education
Bachelor’s degree (Engineering) REQUIRED plus 2-5 years of related work experience with a good understanding of specified functional area, or Master’s degree with 0-2+ years of related work experience, or an equivalent combination of education and work experience.
Experience/Background
Minimum 5+ years related experience in technical or other QA related positions in a regulated industry is preferred.
* Medical Device or Pharma industry experience required
* Previous Quality Engineering experience required.
* Supplier Quality Engineering experience preferred.
* Green Belt certification a plus
(Technical/Business Knowledge (Job Skills)) Working technical knowledge and application of concepts, practices and procedures. General understanding of
business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.;
(Cognitive Skills) Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.