Senior Quality Engineer (2nd Shift)

About the role

This position works out of our St. Paul, Minnesota location in the Vascular Division. This is a fully onsite role and will support second shift. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

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 the investigation, resolution and prevention of product and process nonconformances and CAPAs
• 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
• 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 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

Requirements

• Bachelor’s Degree in Engineering or Technical Field; advanced degree preferred
• Minimum 6+ years of related work experience or an equivalent combination of education and work experience
• Engineering experience and demonstrated use of Quality tools/methodologies

Qualifications

• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

Skills

• Solid communication and interpersonal skills
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
• Advanced computer skills, including statistical/data analysis and technical report writing skills
• Certified Quality Engineer Accreditation

Benefits

• Career development with an international company where you can grow the career of which you dream
• PPO medical plan in the next calendar year
• Adequate 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

Pay

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.

Schedule

This is a fully onsite role and will support second shift.