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 113,000 colleagues serve people in more than 160 countries.

Primary Job Function:

• Independently manage complex; long-duration projects; product improvements and investigations.
• Proactively identify opportunities for significant operational; process; or product improvements.
• Travel: potential to travel up to once per year (e.g., Europe)

Core Job Responsibilities:

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

• Project Management - Independently design; manage; and conduct complex long duration projects; product improvements; and investigations (or supports Third Party Manufacturer projects).
• Product and Process Improvement - Independently manage complex long duration projects; product improvements; and investigations. Recognizes opportunities and proposes novel ideas for significant operational, process or product improvements. Proactively identify opportunities for significant operational, process or product improvements. Perform or support test and process method modifications; considering CQAs; critical process parameters and analytical performance characteristics. Identify technical alternatives and make risk-based decisions within the area. Use technical data that interacts with multiple areas and processes. Provides diverse; independent technical data and insight to support risk management evaluation and assessment.
• Design Control & Risk Management - Effectively balances compliance risk and business risk to create and review risk management files.
• Complaint and Internal Investigations - Independently manages complex investigations to resolution. Demonstrates advanced statistical techniques; MAIC and or project management tools. Provides audit inputs and support as required.
• Technical Support - Assist in resolution of multiple complex technical and quality issues across ADD Sites; TPMs and or functions (instrument; reagents; software and commodities). Anticipate; recognize and resolve technical issues.
• Sharing Knowledge - Presents complex technical information to internal and external groups. Shares scientific information and expertise with customers and regulatory agencies. Experience mentoring and teaching others to facilitate timely resolution of product and process technical issues.
• Strategic and Results Orientation - Demonstrates fiscal responsibility through actionable recommendations and accomplishments. Translates top-level goals to specific goals and aligns activities with respective strategic business priorities.

Position Accountability / Scope:

• Receives infrequent direction; and provides work directions for other technical personnel.
• Identifies; understands and resolves technical problems and operational issues.
• Anticipates and avoids re occurrences.
• Utilizes appropriate experimental, statistical and project management tools.
• Applies specialized knowledge of product or process design; standardization; performance anchors and modes of control to create and review risk management files.
• Maintains detailed knowledge and understanding of product or process design.

Minimum Education, Experience, etc.:

B.S in biological or physical sciences, or mathematics; with minimum of 2-3 yrs.

OR

M.S. with 0 to 2 years’ experience

• Working knowledge of experimental approaches/protocols and scientific methods such as designing experiments and interpreting data.
• Awareness of regulations and standards affecting IVDs and Biologics
• Basic computer skills - able to learn new computer programs

Preferred / Ideal Education, Experience, etc.:

• Above experience and/or relevant knowledge from any of the following types of highly regulated companies /industries: IVD/In Vitro Diagnostics, pharmaceutical, cosmetics, food & beverage, etc.
• Strong proficiency with MS Office, especially PowerPoint.
• Excellent presentation and communication skills, e.g., chairing / running meetings, etc.