Supplier Quality Engineer - Principal Professional Quality

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Summary:

Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes. This position administrates regulatory compliance activities related to internal suppliers for the Abbott Transfusion Medicine division by independently monitoring performance and analyzing supplier quality data, including audit outcomes, to assess compliance to all applicable External Standards and Regulations and Abbott Quality System Requirements.

Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system.

1. General - Develops internal supplier monitoring strategy which is aligned with the business strategy and implements related tactical activities. Translates strategic needs of the division into executable long-range programs and projects. Critically monitors and analyzes quality data; helps identify solutions to a wide range of difficult problems. Solutions are compliant; innovative; thorough; practical and consistent with organizational objectives. Leads projects with cross-functional broader scope. Represents team on cross-functional projects with other functional leaders. Directly influences project direction and scope. Interacts effectively with employees; manager; and cross-functional peers. Excels in effective and positive communications. Contributes functional skills and expertise broadly. Scope includes one or more QA functions with general knowledge of other related disciplines.

2. Quality System Compliance - Demonstrates complete understanding of the standards and regulatory bodies that regulate our industry. Ensures internal suppliers are compliant to Division and Corporate policies and procedures. Implements and maintains effectiveness of ADD's Quality System; including the Subsystems and Key processes that govern the area by identifying compliance risks.

3. Supplier Controls – Develops and executes performance monitoring plans for internal suppliers for the ATM business. Assists with or conducts audits across internal supplier sites to assess compliance to all applicable External Standards and Regulations as well as Abbott Quality System Requirements. Identifies compliance risks to current standards / regulations and may guide in the planning and execution of Quality System improvements. Uses current regulatory trends to identify potential compliance risks or opportunities for improvement in ADD's Quality System. Leads initiatives to address compliance gaps across internal suppliers, including development of CAPA plans and resulting follow-up guidance activities in support of the suppliers to attain the required level of compliance. Reports progress of monitoring and audits within internal supplier sites to Division personnel. Provides guidance to applicable “Inspection-Readiness” activities across ADD Sites. Tracks the progress and completion of audit CAPA plans. Generates and reports internal supplier metrics to Division Management. Maintains files and documentation associated with internal and external inspections

4. Risk Management - Defines the business results expected from risk management strategies and projects. Leads ADD in determining the changes; improvements; and investments needed to support the Risk Management process in the Quality System and business driven objectives. Makes independent decisions within broad parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.

5. Design Control / Documentation & Change Control - Demonstrates a strong working knowledge of the potential global impact of internal supplier changes including safety and efficacy. Evaluates and supplier changes. Identifies key processes that may be impacted as a result of the change. Effectively reviews and discusses changes with key stakeholders.

6. Quality Engineering - Draws conclusions reflecting broad business and quality needs. Champions new initiatives and acts as the catalyst for change within and potentially across divisions. Negotiates complex

quality decisions. Participates as SME in audits. Acts as a consultant in partnership with internal supplier sites for developing quality related strategies for major projects.

7. Validation – Demonstrates general expertise is all aspects of validation for supplier monitoring and audits. Acts as a consultant in partnership with internal supplier sites for developing validation strategies for major projects.

Position Accountability/Scope

Carries out assigned duties and tasks related to area of responsibility with management guidance, may be responsible for decision making. Decisions have long term impact; aligned with the organization strategy. Responsible for ensuring compliant documentation in cross functional areas of support.

Minimum Education

Apprenticeship or Bachelor's degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.

Minimum Experience / Training Required

At least 8 years work experience in Quality or related filed experience; Less experience may be appropriate with advanced degree.

Has experience in the health care industry.

Has a history of completing successful cross-functional projects and driving positive compliance outcomes.

This position can be filled as a Principal Professional Quality or a Senior Professional Quality depending on experience.

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