Abbott
Senior Quality Engineer (2nd Shift)
United States - Minnesota - New Brighton · Senior
Sponsorship not specified$78k-$156kDetected 1 day ago
Data AnalysisProject ManagementProcess ImprovementControlsGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingWritingLean Manufacturing
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Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
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About the role
- Paul, Minnesota location in the Vascular Division.
- Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
- Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.
Responsibilities
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
- Lead the investigation, resolution and prevention of product and process nonconformances and CAPAs
- Lead process control and monitoring of Critical To Quality (CTQ) parameters and specifications
- Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
- Lead in the completion and maintenance of risk analysis in support of the Risk Management Files
- Work with design engineering in the completion of product verification and validation
- Strong 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
Requirements
- Engineering experience and demonstrated use of Quality tools/methodologies
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
- Required Experience:
Nice to have
- advanced degree preferred
- Bachelor's Degree in Engineering or Technical Field
- Preferred Experience:
Skills
- Abbott is a global healthcare leader that helps people live more fully at all stages of life.
- Our 115,000 colleagues serve people in more than 160 countries.
Compensation
- The base pay for this position is
Benefits
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
Company info
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Equal opportunity
- Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
- EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
- EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
This listing is sourced directly from Abbott's careers page and normalized into a canonical job model.