Abbott · 7 hours ago
Process Quality Engineer
St Paul, MN
Full-time
Onsite
Mid Level
$61K/yr - $123K/yr
4+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Process Quality Engineer role involves identifying and implementing effective process control systems, supporting the investigation and resolution of quality issues, and leading various product and process improvement methodologies.
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
Support the investigation, resolution and prevention of product and process nonconformances and CAPAs by our TPM manufacturer
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Assist in the development and execution of streamlined business systems which effectively identify and resolve or prevent quality issues
Lead process control and monitoring of Critical To Quality (CTQ) parameters and specifications at our TPM manufacturer
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 commercial product readiness, transfer to mfg and product verification and validation
Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
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; advanced degree preferred
Minimum 4+ years of related work experience or an equivalent combination of education and work experience
Engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
Preferred
Solid communication and interpersonal skills
Experience working with TPM (Third Party Manufacturers)
Advanced computer skills, including statistical/data analysis and technical report writing skills
Certified Quality Engineer Accreditation
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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