Quality Engineer I

Abbott • Scarborough, ME

1d • $50,700 - $101,300 • Onsite

About The Position

The Quality Engineer I works at Abbott’s Scarborough, Maine location in the Infectious Disease, Diagnostics Division. The role supports product quality assurance, process improvement, quality system programs, qualification and validation, supplier quality management, and compliance with applicable FDA and ISO requirements. The position partners with Manufacturing, Operations, Engineering, and other cross-functional teams to help ensure that products and processes consistently meet quality and regulatory requirements.

The role also supports Operations and performs related duties and special projects as assigned. It requires compliance with FDA regulations, ISO standards, company policies, operating procedures, and quality system requirements, and includes responsibility for using and maintaining the effectiveness of the Quality Management System. The position maintains collaborative relationships with employees, customers, suppliers, and other business partners.

Requirements

• Bachelor’s degree in Engineering, Chemistry, Biotechnology, Life Science, or another related technical discipline, or an equivalent combination of education and experience.
• Working knowledge of FDA, cGMP, Quality System Regulations (QSR), and ISO quality system requirements.
• Knowledge of quality engineering principles, investigations, root cause analysis, and process improvement methodologies.
• Strong technical writing, analytical, and problem-solving skills.

Nice To Haves

• Experience working within FDA- and ISO-regulated environments.
• Experience with statistical analysis tools such as Minitab or JMP.
• Experience with quality systems software, supplier quality programs, or validation activities.

Responsibilities

• Review qualifications, validations, and technical studies for technical content, statistical rationale, sampling plans, unintended impact, and compliance requirements.
• Serve as the Quality representative for qualification and validation review and approval activities.
• Support the Material Review Board (MRB) process and maintain processes for managing nonconforming materials and processes.
• Review and participate in disposition of nonconforming materials and quality incidents, ensuring appropriate data, testing, documentation, and decisions are completed.
• Act as a technical resource to support timely, customer-focused resolution of quality issues.
• Support supplier quality management activities and maintain supplier quality documentation and processes.
• Review and approve reports and documentation associated with design changes and potentially lead quality-related design change projects.
• Develop and support Quality Assurance training programs.
• Develop test plans, inspection plans, and quality-related procedures.
• Review manufacturing, process, procedure, and material changes from a quality and compliance perspective.
• Support process data collection, statistical analysis, and continuous improvement initiatives.
• Support internal and external audit programs and track audit findings through completion.
• Comply with FDA regulations, ISO standards, company policies, operating procedures, and quality system requirements.
• Utilize and maintain the effectiveness of the Quality Management System.
• Maintain positive and collaborative relationships with employees, customers, suppliers, and other business partners.
• Support Operations and perform related duties and special projects as assigned.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, offering an affordable and convenient path to earning a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level