Instrument Quality Engineer

Abbott • South Portland, ME

18d

About The Position

Join our team as an Instrument Quality Engineer and play a key role in maintaining and improving our quality system. This position offers an opportunity to work on critical processes that ensure product excellence and compliance.

Requirements

• Bachelor's Degree in Engineering, Healthcare or Life Science.
• Direct experience in a Quality or Regulatory Affairs role in a GMP related industry.

Responsibilities

• Actively monitor Third-Party Manufacturers’ data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory requirements (cGMP, ISO).
• Review GMP-related documentation for compliance, including batch records and associated manufacturing, testing, and release data; validation protocols and reports; labels; product specifications; and additional documentation as required.
• Participate in the Corrective Action/Preventive Action (CAPA) process, including investigations of failures or deviations in the Manufacturing area, as needed.
• Maintain product complaint logs to identify and report recurring issues to Quality Assurance management and product development.
• Collaborate with internal teams to address product inquiries and issues.
• Write and revise SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.
• Collaborate with members of the Quality Assurance team on special projects.
• Participate on permanent and temporary process- or project-driven teams.
• Develop familiarity and subject matter expertise in electronic support systems such as TraqWise, GQMS, Team Center, Compliance Wire.
• Collect, analyze, and publish quality metrics.
• Provide data to support budgetary submissions.
• Assist with other support duties as assigned.

Benefits

• Career development with an international company where you can grow the career you dream of.
• 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees