Associate Quality Engineer (second shift 3:30pm to 2:00am)

Abbott (abbottcareers2 board); United States; On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

Employer retirement contribution

Tuition reimbursement

FreeU education benefit

Global career development

Job summary

Abbott is seeking an Associate Quality Engineer for the Westford, MA site in the Abbott Vascular Division. The role is on-site with a 3:30pm–2:00am second shift, focusing on developing and maintaining quality engineering methodologies across new product development, manufacturing, and system/services support.

You will lead CAPA, process controls, and risk analyses, collaborating with design engineering and microbiology to ensure compliance with FDA regulations and internal quality standards.

Qualifications

• Bachelor's degree in engineering or technical field or equivalent experience.
• 0-2+ years engineering experience and demonstrated use of quality tools/methodologies.
• Strong communication and interpersonal skills; project management and leadership abilities.

Responsibilities

• Develop and maintain quality engineering methodologies across new product development, manufacturing, or system/services support.
• Identify and implement effective process control systems to support development and manufacturing.
• Lead in the implementation of CAPA, process controls, and quality assurance activities.
• Apply systematic problem-solving methodologies to identify, prioritize, and resolve quality issues.
• Design and conduct experiments for process optimization and improvement; document plans and results.
• Lead risk analysis, product verification and validation activities with design engineering and microbiology as needed.

Skills

Quality tools/methodologies

Project management

Leadership

Communication

Education

Bachelor's degree in Engineering or Technical Field

Tools

Six Sigma

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 122,000 colleagues serve people in more than 160 countries.

Job Title

Associate Quality Engineer (second shift - 3:30pm to 2:00am)

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 Westford, MA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

This is an onsite role. Schedule is Monday - Thursday, 10-hour shifts.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents

What You'll Work On

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

MAIN RESPONSIBILITIES

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
• Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
• Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Design and conduct experiments for process optimization and/or improvement
• Appropriately document experiment plans and results, including protocol writing and reports
• Lead process control and monitoring of CTQ parameters and specifications
• Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
• Lead the investigation, resolution and prevention of product and process non-conformances
• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
• Lead in the completion and maintenance of risk analysis
• Work with design engineering in the completion of product verification and validation
• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Experience

Bachelors Degree Engineering or Technical Field or equivalent experience or an equivalent combination of education and work experience.

0-2+ years Engineering experience and demonstrated use of Quality tools/methodologies.

Solid communication and interpersonal skills. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.

Advanced computer skills, including s