JOB DESCRIPTION:The OpportunityThis position works out of our
Scarborough, ME location in the
Infectious Disease, Diagnostics Division. We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.
The
Quality Engineer I role will be responsible for supporting product quality assurance activities, process improvement initiatives, quality system programs, qualification and validation activities, supplier quality management activities, and compliance with applicable FDA and ISO requirements. This position partners with Manufacturing, Operations, Engineering, and other cross-functional teams to ensure products and processes consistently meet quality and regulatory requirements.
What You'll Work On- Reviews qualifications, validations, and technical studies for technical content, statistical rationale, sampling plans, unintended impact, and compliance requirements.
- Serves as the Quality representative for qualification and validation review and approval activities.
- Supports the Material Review Board (MRB) process and maintains processes for managing nonconforming materials and processes.
- Reviews and participates in the disposition of nonconforming materials and quality incidents to ensure appropriate data, testing, documentation, and decisions are completed.
- Acts as a technical resource to support timely and customer-focused resolution of quality issues.
- Supports supplier quality management activities and maintains supplier quality documentation and processes.
- Reviews and approves reports and documentation associated with design changes and may serve as project lead for quality-related design change activities.
- Develops and supports Quality Assurance training programs.
- Develops test plans, inspection plans, and quality-related procedures.
- Reviews manufacturing, process, procedure, and material changes from a quality and compliance perspective.
- Supports process data collection, statistical analysis, and continuous improvement initiatives.
- Supports internal and external audit programs and tracks audit findings through completion.
- Complies with FDA regulations, ISO standards, company policies, operating procedures, and quality system requirements.
- Responsible for utilizing and maintaining the effectiveness of the Quality Management System.
- Maintains positive and collaborative relationships with employees, customers, suppliers, and other business partners.
- Supports Operations and performs related duties and special projects as assigned.
Required Qualifications- Bachelor's Degree (BS) in Engineering, Chemistry, Biotechnology, Life Science or other related technical discipline, or 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.
Preferred Qualifications- 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.
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:ID Infectious Disease
LOCATION:United States > Scarborough : 10 Southgate Rd
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis, Work in noisy environment, Work requiring repeated bending, stooping, squatting or kneeling
