Process Quality Engineer

Process Quality Engineer
 

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career of which you dream.
• 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.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

This position works out of our St. Paul, MN (New Brighton) location in the Abbott Vascular division. 

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

• →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.

• 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

• 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

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