Quality Engineer I – Growth & Impact (2nd Shift)

Regulatory Jobs; Westford (MA); On-site; USD 51,000 - 101,000; Full time

Benefits offered by this job

HIP PPO medical plan

Strong retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Vascular is seeking an Associate Quality Engineer for the second shift in Westford, MA. The role focuses on developing quality engineering methodologies and providing support across new product development, manufacturing, and system services within a GMP/ISO context.

The position emphasizes process controls, CAPA, risk management, and collaboration with design engineering and microbiology to ensure robust QA throughout product lifecycles.

Qualifications

• Bachelor's Degree in Engineering or Technical Field.
• 0-2+ years Engineering experience and demonstrated use of Quality tools/methodologies.
• Solid communication and interpersonal skills; project management and leadership abilities.
• Advanced computer skills including statistical/data analysis and report writing.
• Prior medical device experience preferred; Six Sigma/Lean Manufacturing experience; CQE preferred.
• Experience working in a matrixed, cross-divisional environment.
• Ability to work as a team member and individual contributor in a fast-paced setting.

Responsibilities

• Develop and maintain quality engineering methodologies across new product development, manufacturing, and system/services support.
• Identify and implement effective process control systems for development and on-going manufacturing.
• Lead in the implementation of assurances, process controls, and CAPA systems.
• Assist in developing and executing streamlined business systems to identify and resolve quality issues.
• Design and conduct experiments for process optimization and improvement; document plans and results.
• Lead process control and monitoring of CTQ parameters and specifications; drive product/process improvements.
• Investigate, resolve, and prevent product and process non-conformances.
• Collaborate with design engineering and microbiology to ensure QA integration across development.

Skills

Quality tools/methodologies

Communication skills

Project management

Data analysis

Cross-functional teamwork

Lean Six Sigma

Medical device experience

Education

Bachelor's Degree in Engineering or Technical Field

Tools

Statistical software

Job description

Abbott Vascular is seeking an Associate Quality Engineer for the second shift in Westford, MA. The role focuses on developing quality engineering methodologies and providing support across new product development, manufacturing, and system services within a GMP/ISO context.

The position emphasizes process controls, CAPA, risk management, and collaboration with design engineering and microbiology to ensure robust QA throughout product lifecycles.