Process Quality Engineer

abbott; Saint Paul (MN); On-site; USD 61,300 - 122,700; Full time

Benefits offered by this job

Career development

Free medical coverage

Excellent retirement savings plan

Tuition reimbursement

Recognition as a great place to work

Job summary

Abbott is seeking a Process Quality Engineer in St. Paul, MN to enhance product quality and ensure regulatory compliance. This role involves identifying effective process controls, resolving quality issues, and collaborating with various teams.

The ideal candidate holds a Bachelor's degree in Engineering, possesses at least 2 years of relevant experience, and demonstrates strong skills in quality tools and methodologies. Abbott offers competitive benefits such as free medical coverage, tuition reimbursement, and a robust retirement plan.

Qualifications

• Minimum 2 years of related work experience or an equivalent combination of education and work experience.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.

Responsibilities

• Identify and implement effective process control systems.
• Support investigation and resolution of product nonconformances.
• Apply systematic problem-solving methodologies.
• Develop streamlined business systems for quality issues.
• Lead process control monitoring of Critical To Quality parameters.
• Implement product and process improvement methodologies.
• Participate in supporting quality discipline decisions.
• Maintain positive communication with employees and vendors.

Skills

Quality tools/methodologies

Solid communication skills

Statistical/data analysis skills

Technical report writing skills

Education

Bachelor’s Degree in Engineering or Technical Field

Advanced degree preferred

Job description

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.