Associate Quality Engineer – Med Devices, Process Improvement

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

Benefits offered by this job

Health coverage option

Retirement plan

Tuition reimbursement

Job summary

Abbott is seeking an Associate Quality Engineer for the Westford, MA site (second shift 3:30pm–2:00am) to develop and maintain quality engineering methodologies across new product development, manufacturing, and services support. This onsite role emphasizes process control, CAPA, and cross-functional teamwork.

The ideal candidate brings a engineering degree and 0–2+ years with quality tools, strong communication, and a drive to resolve issues quickly.

Qualifications

• Bachelor's degree in Engineering or Technical Field or equivalent
• 0-2+ years Engineering experience and demonstrated use of Quality tools/methodologies
• Solid communication and interpersonal skills
• Project management and leadership skills, including ability to lead multi-departmental project teams and resolve quality-related issues
• Advanced computer skills, including statistical/data analysis and report writing skills
• Prior medical device experience preferred
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
• ASQ CQE or other certifications preferred
• Experience working in a broader enterprise/cross-division business unit model preferred
• Ability to work in a highly matrixed and geographically diverse business environment
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in timely manner
• Strong organizational and follow-up skills, as well as attention to detail
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

Responsibilities

• Identify and implement effective process control systems to support development, qualification, and on-going manufacturing of products
• Lead in the implementation of assurances, process controls, and CAPA systems
• Assist in the development and execution of streamlined business systems which 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 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 and decisions
• Lead in the completion and maintenance of risk analysis
• Work with design engineering in product verification and validation
• Work with microbiology to ensure environmental monitoring and microbiology requirements are considered
• Support QMS, EMS and other regulatory requirements

Skills

Quality tools

Project management

Communication skills

Team leadership

Problem solving

Education

Bachelor's degree in Engineering or Technical Field

Tools

Six Sigma

Lean Manufacturing

Job description

Abbott is seeking an Associate Quality Engineer for the Westford, MA site (second shift 3:30pm–2:00am) to develop and maintain quality engineering methodologies across new product development, manufacturing, and services support. This onsite role emphasizes process control, CAPA, and cross-functional teamwork.

The ideal candidate brings a engineering degree and 0–2+ years with quality tools, strong communication, and a drive to resolve issues quickly.