Abbott Change & Design Control Expert in Abbott Park, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Participates in / leads multiple complex projects defined for expanded investigations,design changes,resolving on-market product problems and resolving technical issues to increase product availability.
Additional Main Responsibilities
Quality/Safety: Demonstrate an understanding of the application of the Quality Policy through daily activities.
Maintain vigilance to ensure adherence to the Quality Policy and system procedures by promptly reporting noncompliance issues to management.
Safety: Work in a safe and environmentally responsible manner. b.
Technical knowledge: Develop and apply operations/ product/ process knowledge to (area of support). Use sound judgment,appropriate scientific methods and thorough data analysis.
Accurately documents work. c.
Planning/Project Management: Conceive,plan,design,execute,and document projects/activities efficiently and in conformance with applicable Ops d.
Patient Focus: Anticipates,identifies and resolves internal and external customer issues through understanding of processes,product performance and clinical utility. e.
Communication/Leadership: Demonstrates effective verbal and written communication skills within and outside immediate area.
Shares and enhances own knowledge by mentoring and training others. f.
Business Focus/Alignment: Demonstrates fiscal responsibility through actionable recommendations and accomplishments such as maintaining product availability and improvements in product sustainability.
Aligns resources with strategic business priorities May perform other duties as assigned.
Takes initiative,makes decisions,and takes appropriate risks to accomplish team projects and goals.
Works independently,anticipating workflow while coordinating activities. b.
Listens actively,fosters information exchange,provides scientific and operational information effectively,establishes networks,and presents/defends positions.
Makes sound technical and operational decisions.
Mentors others on their technical writing skills for data analysis,expanded investigation documents,design change documents and change control. c.
Confronts issues,motivates and influences others,negotiates and manages crisis,to attain desired results.
Utilizes experience to mentor team members and others.
Ensures team is compliant with QSR / ISO requirements d.
Cultivates relationships with internal and external customers.
Understands and identifies team contribution to long range plans.
Provides feedback to team members and identifies strengths and areas for improvement.
Influences development and achievement of team and project goals/timelines. e.
Recognizes and promotes acceptance of changes in internal/external environment.
Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role.
Bachelor’s degree required in a scientific / technical discipline plus 4 years experience in a related scientific / technical field OR 10 years of practical experience in a manufacturing,testing or technical roles to demonstrate functional equivalence. Advanced degree(s) may offset required years of experience. Required: Minimum of 4 years experience in a related scientific / technical field. Advanced degree(s) may offset required years of experience. Preferred: Experience with computer and data management. Experience working in project teams for basic projects or a single complex project. Experience with change control and/or investigation processes and/or laboratory skills. Experience with acquiring, analyzing and interpreting data. Understanding change control impact on design / validation of products and/or processes. Experience in operations (manufacturing/quality). Demonstrated ability to apply operations knowledge in timely resolution of product / process technical issues. Experience mentoring / teaching others to facilitate timely resolution of product / process technical issues. Previous experience with immunoassays within a family (disease state), multiple technologies, multiple clinical utilities and Abbott systems. Experience interacting with customers to resolves issues. Knowledge of experimental design and statistical tools.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org