Manufacturing Line Quality Assurance Specialist

3 days ago


Scarborough, Maine, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott Laboratories 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 Opportunity

We are seeking a highly skilled Manufacturing Line Quality Engineer to join our team in Scarborough, Maine. In this role, you will play a critical part in ensuring the quality and safety of our products.

Key Responsibilities
  • 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.
  • Complete risk assessments, root cause investigations, and action plans for non-conformances (NC) and corrective and preventive actions (CAPA).
  • Perform risk management activities using Failure Mode and Effect Analysis (FMEA) methodologies.
  • Review proposed changes, perform risk assessments, and assess the adequacy of verifications and validations.
  • Review qualifications, validations, and other studies for technical content, statistical and sampling rationale, unintended impact, and clarity.
  • Participate in design transfer and improvement project teams.
Requirements
  • 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.
What 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 and 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, with specific locations having varying pay ranges.



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