Intermediate Quality Engineer
Abbott Laboratories
Summary
This position supports our Princeton, NJ location within the Point of Care business. As an Intermediate Quality Engineer, you'll partner with Operations to help ensure manufacturing processes, materials, and products meet quality and regulatory requirements. You'll support validation and qualification activities, investigate quality issues, review production documentation, and assess materials for commercial release while contributing to process improvement and operational excellence.
Job description
The Opportunity
This position supports our Princeton, NJ location within the Point of Care business. As an Intermediate Quality Engineer, you'll partner with Operations to help ensure manufacturing processes, materials, and products meet quality and regulatory requirements. You'll support validation and qualification activities, investigate quality issues, review production documentation, and assess materials for commercial release while contributing to process improvement and operational excellence.
What You'll Work On
- Partner with Operations as a Quality representative to review production records, executed test methods, and material disposition decisions before commercial distribution.
- Review process and test method validation, equipment and facility qualification documentation, and calibration records; identify and resolve deficiencies before commercial use.
- Support nonconformance and deviation investigations, assess process risks, recommend mitigations, and help improve manufacturing and quality processes.
- Review and approve standard operating procedures and manufacturing work instructions, and conduct production-area audits to maintain compliance with cGMP, ISO, and internal quality standards.
- Collaborate with cross-functional teams to resolve day-to-day quality concerns, maintain accurate documentation, and support continuous improvement.
Required Qualifications
- Bachelor's degree in engineering, science or a related field; or an associate degree in a related field with an additional two years of experience
- 2+ years of experience in a manufacturing operations environment
- 1+ years of experience applying quality principles and practices
- Knowledge of and experience working within a 21 CFR Part 820, ISO 13485, and/or cGMP-regulated environment
- Strong communication and collaboration skills with the ability to work effectively across Operations and Quality teams
- Ability to meet applicable PPE requirements and perform role-related physical activities, including lifting up to 40 pounds, with or without reasonable accommodation
- Authorization to work in the United States without sponsorship
Preferred Qualifications
- 2+ years of experience in biotechnology manufacturing, preferably in a GMP and/or ISO 13485 environment
Requirements
- Bachelor's degree in engineering, science or a related field; or an associate degree in a related field with an additional two years of experience
- 2+ years of experience in a manufacturing operations environment
- 1+ years of experience applying quality principles and practices
- Knowledge of and experience working within a 21 CFR Part 820, ISO 13485, and/or cGMP-regulated environment
- Strong communication and collaboration skills with the ability to work effectively across Operations and Quality teams
- Ability to meet applicable PPE requirements and perform role-related physical activities, including lifting up to 40 pounds, with or without reasonable accommodation
- Authorization to work in the United States without sponsorship
- 2+ years of experience in biotechnology manufacturing, preferably in a GMP and/or ISO 13485 environment
Benefits
- Medical Coverage
- Retirement Savings Plan
- Tuition Reimbursement
- Student Debt Program
- Education Benefit
Company overview
Abbott Laboratories is a global healthcare technology leader founded in 1888 and headquartered in Chicago, Illinois. As an international medtech and pharmaceutical company, Abbott operates in approximately 160 countries worldwide with a workforce of over 115,000 employees. The company is organized into four major business segments: Medical Devices (48% of revenue), Diagnostics (20%), Nutritional Products (19%), and Established Pharmaceutical Products (12%). Abbott's medical devices portfolio includes revolutionary technologies such as the FreeStyle Libre continuous glucose monitoring system for diabetes management, cardiovascular devices like the MitraClip and TriClip for heart valve repair, and neuromodulation systems for chronic pain management. The company's diagnostics division pioneered breakthrough tests including the first licensed HIV blood test in 1985. With a rich history spanning over 135 years, Abbott has consistently been recognized as one of Fortune's World's Most Admired Companies since 1984 and continues to drive innovation in healthcare technology to help people live healthier, fuller lives.