Manufacturing Line Quality Engineer at Abbott Laboratories

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. Our 114,000 colleagues serve people in more than 160 countries.

About Abbott

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Our location in Scarborough, Maine currently has an opportunity for a

Manufacturing Line Quality Engineer to join our team. In this role, you will support contract manufacturing, product quality assurance, change management, process improvements, and quality system programs.

WHAT YOU’LL DO 

• Production Support: Resolve quality issues on the manufacturing floor, ensuring adherence to procedures and proper documentation of device history records (DHR). Support line clearances, reworks, and inspections as needed.
• NC and CAPA Processes: Complete risk assessments, root cause investigations, and action plans for non-conformances (NC) and corrective and preventive actions (CAPA).
• Risk Management: Perform risk management activities using Failure Mode and Effect Analysis (FMEA) methodologies (e.g., dFMEA, pFMEA). Support peers in developing and verifying the effectiveness of mitigations for failure modes.
• Change Control: Review proposed changes, perform risk assessments, and assess the adequacy of verifications and validations.
• Qualifications and Validations: Review qualifications, validations, and other studies for technical content, statistical and sampling rationale, unintended impact, and clarity. Act as the Quality representative for qualification and validation approvals for all validated equipment.
• Project Participation: Participate in design transfer and improvement project teams.
• Quality Management System: Demonstrate commitment to the development, implementation, and effectiveness of the Quality Management System per ISO, FDA, and other regulatory agencies.
• Professional Behavior: Exhibit professional behavior with internal and external business associates that reflects positively on the company and aligns with company policies and practices.
• Quality Awareness: Understand and be aware of the quality consequences that may result from improper performance of job responsibilities. Be aware of potential device defects in areas of responsibility, including product design, verification and validation, manufacturing, and testing activities.
• Additional Duties: Perform other duties as assigned, according to the changing needs of the business.

EDUCATION AND EXPERIENCE YOU’LL BRING 

REQUIRED 

• Bachelor’s degree in Engineering, Chemistry, Biotechnology, Life Science, or another technical field, or an equivalent combination of education and experience.
• Knowledge of Ensure and Agile programs.
• Working knowledge of Database software, Internet software, Inventory software, Spreadsheet software, and Word Processing software.
• Working knowledge of FDA, cGMPs/QSR, and ISO quality system requirements.
• Strong technical writing skills and effective communication skills.

Preferred:

• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification.

WHAT WE OFFER  

At Abbott, you can have a good job that can grow into a great career. We offer: 

·       A FAST-PACED WORK ENVIRONMENT where your safety is our priority

·       Production areas that are CLEAN, WELL-LIT AND TEMPERATURE-CONTROLLED

·       TRAINING AND CAREER DEVELOPMENT, with onboarding programs for new employees and tuition assistance  

·       FINANCIAL SECURITY through competitive compensation, incentives and retirement plans  

·       HEALTH CARE AND WELL-BEING PROGRAMS including medical, dental, vision, wellness and occupational health programs 

·       PAID TIME OFF  

·       401(K) retirement savings with a generous company match 

·       THE STABILITY OF A COMPANY with a record of strong financial performance and history of being actively involved in local communities 

The base pay for this position is $48,000.00 – $96,000.00. In specific locations, the pay range may vary from the range posted.