Quality Engineer II

Abbott Laboratories • Minnetonka, MN

83d • $60,000 - $120,000

About The Position

The Quality Engineer II position at Abbott is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. This role is situated in the Cardiac Rhythm Management division, focusing on innovative technologies that improve the treatment of heart arrhythmias. The position involves identifying and implementing effective process control systems, leading the implementation of assurances and CAPA systems, and assisting in the development of streamlined business systems to resolve quality issues. The Quality Engineer II will also design and conduct experiments for process optimization, document experiment plans and results, and lead various product and process improvement methodologies such as Six Sigma and Lean Manufacturing.

Requirements

• Bachelor's Degree in Engineering or Technical Field or equivalent experience.
• Minimum 2-5 years of Engineering experience with demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Solid communication and interpersonal skills.
• Project management and leadership skills.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong verbal and written communication skills.
• Ability to multitask, prioritize, and meet deadlines.
• Strong organizational and follow-up skills, with attention to detail.

Nice To Haves

• Master's Degree preferred.
• Advanced computer skills, including statistical/data analysis and report writing.
• Prior medical device experience preferred.
• Experience implementing product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.

Responsibilities

• Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products.
• Lead in the implementation of assurances, process controls, and CAPA systems.
• Assist in the development and execution of streamlined business systems to identify and resolve quality issues.
• Apply systematic problem-solving methodologies to resolve quality issues.
• Design and conduct experiments for process optimization and improvement.
• Document experiment plans and results, including protocol writing and reports.
• Lead process control and monitoring of CTQ parameters and specifications.
• Implement product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Lead the investigation, resolution, and prevention of product and process non-conformances.
• Participate in or lead teams supporting quality disciplines and practices.
• Complete and maintain risk analysis.
• Work with design engineering on product verification and validation.
• Collaborate with microbiology to ensure environmental monitoring and microbiology requirements are met.
• Support all Company initiatives in line with Quality Management Systems (QMS) and regulatory requirements.

Benefits

• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan.
• Excellent retirement savings plan with high employer contribution.
• Tuition reimbursement and Freedom 2 Save student debt program.
• FreeU education benefit for obtaining a bachelor's degree.
• Recognition as a great place to work and for diversity.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree