Process Quality Engineer

Job Title Process Quality Engineer Location St. Paul, MN (New Brighton), Abbott Vascular Overview Abbott Vascular provides innovative, minimally invasive and cost-effective products for the treatment of vascular disease, including drug‑eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters, software, vessel closure devices and peripheral stents. What You’ll Do Identify and implement effective process control systems to support the development, qualification, and ongoing 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 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 manufacturing 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 Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors Minimum Experience / Training Required Bachelor’s Degree in Engineering or Technical Field; advanced degree preferred Minimum 2 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 Experience 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 Career development with an international company 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 A company recognized as a great place to work in dozens of countries and named one of the most admired companies by Fortune Recognition as one of the best big companies to work for, and a best place for diversity, working mothers, female executives, and scientists EEO Statement Abbott is an Equal Opportunity Employer, committed to employee diversity. Compensation The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr