Lead Engineer (Design Quality Assurance)

Abbott; Princeton (NJ); On-site; USD 87,000 - 173,000; Full time

Job summary

Abbott in Princeton, NJ is seeking a Lead Engineer (Design Quality Assurance) to join the Abbott Point of Care Diagnostics Division. You will lead design quality activities, guide multi-disciplinary teams, and ensure FDA QSR and Design Control compliance across development.

Responsibilities include defining verification/validation requirements, reviewing Design Control elements (Planning, Device History File, Change Control), analyzing data to support decisions, and providing training.

Qualifications

• B.Sc. in science or engineering.
• 6-10 years general work experience.
• 4-6 years QA experience in medical device manufacturing or pharmaceutical industries.
• Design Control experience required.

Responsibilities

• Provide on-market QA support for design control activities.
• Guide multi-disciplinary teams to meet quality standards and objectives.
• Define document requirements for verification and validation per FDA QSR.
• Review and approve Design Control elements (Planning, Device History File, Change Control).
• Lead training and ensure compliance across site procedures.

Education

B.Sc. in science or engineering

Job description

Abbott 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 115,000 colleagues serve people in more than 160 countries.

Lead Engineer (Design Quality Assurance)

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to :

• 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.

The Opportunity

This position works out of our Princeton, NJ location in the Abbott Point of Care 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 Lead Engineer (Design Quality Assurance) will work in the Quality Assurance organization at the Abbott Point of Care Princeton.

What You’ll Work On

• Primary on-market quality assurance support for design control activities.
• Provide guidance and direction to multi-disciplinary personnel involved in product development and production to arrive at solutions that support the company’s business objectives and quality standards.
• Able to define document requirements for products, process and test methods verifications and validations in accordance with FDA QSR’s and specific Design Control projects activities.
• Understanding of process, design and product/design verification/validation.
• Able to relate information to specifications, product claims and design.
• Uses clinical knowledge, understanding of competitor’s products, and extrapolation from limited data to assure fitness for use.
• Responsible for implementation of design control policies and procedures.
• Contributes to the design, development and implementation of comprehensive product assurance plans providing feedback and corrective action for engineering, manufacturing, service and field operations and suppliers performance.
• Liaises with project and program team members on technical and quality matters.
• Analyzing and interpreting data will be an integral part of the daily responsibilities.
• Able to utilize data to make driven decisions and recommendations.
• Provide and / or participate in Design Control training.
• Responsible for review and approval of elements of Design Control including but not limited to : Planning, Device History File(s), Change Control and associated and supporting documentation.
• May have responsibilities for review and approval of DMF, DMR, MVP, and FMEA.
• Ensures that quality and compliance with site procedures are communicated and implemented.

Required Qualifications

• B.Sc. in science or engineering.
• 6-10 years of general work experience
• 4-6 years of Quality Assurance experience in medical device manufacturing or pharmaceutical industries.
• Design Control Experience is required.

Preferred Qualifications

• Knowledge of Process Validation is an asset
• Membership on the American Society of Quality Control (ASQ) or Society of Reliability Engineers is an asset.
• Good knowledge of quality regulations and standards, statistical calculation and measurement and manufacturing processes.
• Strong knowledge of inspection methods in design, fabrication and production of electronic equipment. Demonstrated skill in using test and measuring equipment. Working knowledge of GMP, ISO standards, FDA regulations, and Health Canada.
• Superior analytical and problem-solving skills and statistical applications experience.
• Ability to be creativity in achieving objectives while assuring compliance with internal and external requirements.
• Proven organizational and leadership skills. Ability to work under pressure in a fast-paced environment.
• Excellent oral and written communication skills and ability to interact effectively with all levels in the organization.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is $86,700.00 - $173,300.00. In specific locations, the pay range may vary from the range posted.