Quality Engineer I

Responsibilities

• Identify and implement effective process control systems to support product development, qualification, and manufacturing.
• Lead the implementation of assurances, process controls, and CAPA systems to meet internal and external requirements.
• Apply systematic problem-solving methodologies to identify, prioritize, and resolve quality issues.
• Design and conduct experiments for process optimization, including protocol writing and reporting results.
• Lead the investigation, resolution, and prevention of product and process non-conformances.
• Support risk analysis completion and work with design engineering on product verification and validation.
• Implement product and process improvement methodologies such as Six Sigma and Lean Manufacturing.
• Ensure compliance with FDA regulations, GMP, and other regulatory requirements.

Requirements

• BS degree in Engineering, a Technical Field, or equivalent experience.
• Minimum 2 years of Engineering experience with demonstrated use of Quality tools and methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Strong statistical and data analysis skills along with report writing proficiency.
• Proven project management and leadership skills, including the ability to lead multi-departmental teams.
• Excellent verbal and written communication skills for collaborating across all levels of the organization.

Preferred Qualifications

• Master's Degree in a relevant field.
• Prior experience in the medical device industry.
• Experience with Six Sigma or Lean Manufacturing methodologies.
• ASQ CQE or other relevant quality certifications.

Benefits

• Training and career development programs and tuition assistance.
• Competitive compensation, incentives, and retirement plans with company match.
• Comprehensive healthcare including medical, dental, vision, and wellness programs.
• Paid time off and 401(k) savings plans.

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.