Abbott · 6 hours ago
Quality Engineer I
Plymouth, MN
Full-time
Onsite
New Grad, Entry Level
$51K/yr - $101K/yr
0+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Quality Engineer I position involves ensuring that new or modified products conform to requirements and establishing compliance with the quality system, while collaborating with cross-functional teams to protect patient safety and meet business needs.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
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 in the implementation of assurances, process controls, and CAPA systems designed 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
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Design and conduct experiments for process optimization and/or improvement
Appropriately document experiment plans and results, including protocol writing and reports
Lead process control and monitoring of CTQ parameters and specifications
Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
Lead the investigation, resolution and prevention of product and process non-conformances
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
Work with design engineering in the completion of product verification and validation
Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Qualification
Required
Bachelor's degree in engineering or Technical Field or an equivalent combination of education and work experience
0-2 years Engineering experience
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes, and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
Preferred
Prior medical device experience preferred
Experience working in a broader enterprise/cross-division business unit model preferred
CAPA owner or a key cross-functional team member leading a CAPA project
Use of quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
Risk management, post market surveillance, and manufacturing analysis
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
An excellent retirement savings plan with high employer contribution
Tuition reimbursement
The Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
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