Senior Quality Engineer (2nd Shift)

Abbott • New Brighton, MN

6d • $78,000 - $156,000 • Onsite

About The Position

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. The Senior Quality Engineer will be responsible for providing quality engineering support and leadership within product manufacturing, design transfer, and process/system/services in the manufacturing of Class II & III medical devices. In addition, they will provide daily quality engineering support to resolve production issues and maintaining process stability. Will support manufacturing line for any issues on manufacturing or production lines.

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

Nice To Haves

• 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

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
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior