Abbott Senior Quality Engineer in St. Paul, Minnesota
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.
We are seeking an experienced, high caliber Senior Quality Engineer to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, and system/services support.
Duties and Responsibilities
Supervises QE Technicians in daily responsibilities/priorities
Leads the investigation, resolution and prevention of product and process nonconformance; owns and investigates CAPAs as necessary to address root cause.
Identifies and implements effective process control tactics, assurances, and CAPA systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Design and conduct experiments for process optimization and/or improvement
Appropriately document experiment plans and results, including protocol writing and reports
Lead and mentor teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
Identifies and implements effective process control tactics to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Leads process control and monitoring of CTQ parameters and specifications.
Leads in the completion and maintenance of risk analysis (PFMEA).
Leads design transfer activities for new product development; establishes process verification and validation requirements through master validation plans.
Train others on processes and procedures impacting component and/or product quality.
Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
Works well with other engineers in a collaborative, fast-paced goal-driven environment.
Possesses interpersonal skills to negotiate and reconcile differences.
Experience and Required Education
5-7 years experience is typical for this position.
BS degree in Engineering or Technical Field or equivalent experience
Exceptional communication and interpersonal skills
Operations and/or Design Experience.
Electrical and Systems Engineering Experience
Familiar with modern computer architecture and assembly.
Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
Engineering experience and demonstrated use of Quality tools/methodologies
Six Sigma and/or Lean Manufacturing
Working knowledge of FDA, GMP, ISO 13485, and/or ISO 14971
Advanced information systems skills, information retrieval and interpretation, and report writing skills
ASQ, CQE or other certifications
Medical Device Quality Experience
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 email@example.com