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Sr. Quality Engineer

Abbott Laboratories Westford, MA
  • Posted: 4 days ago
  • Other

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 103,000 colleagues serve people in more than 160 countries.

Job Summary:

This position will be a sustaining design quality engineering position supporting the FFR and OCT hardware portion of our business

Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in

planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. Remains abreast

of and consults on technical advancements. Identifies and routinely uses the most effective and cost-efficient practices to execute

processes; continually evaluates their effectiveness and appropriateness.

Job Duties:

• Support all sustaining activities around catheter and capital hardware console manufacturing including end of life, supplier change

requests, Global compliance standards, IFU/Label changes, support of regulatory submissions, corporate programs, literature review,

and all supporting quality system elements

• The position will also support the following manufacturing elements:

• Production support process validation, and design changes and design verification and validation

• Interface with vendors for components

• Support CAPA investigations

• Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.

• Protocol and report writing

• Work with cross functional teams as required

• Develop and implement process improvements

• 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.

• Performs other related duties and responsibilities, on occasion, as assigned.

Equipment:

 Works with standard office equipment such as telephone, cellular phone, fax/copier, and a personal computer with standard office software.

·         Knowledge of analog electronics

·         Experience with fiber optics is beneficial

·         Working knowledge of laser equipment is beneficial

·         Capital equipment experience is preferred

Works primarily in a standard office environment with air conditioning, good lighting with a low to moderate noise level. May also visit

research labs, testing labs, production and other areas as well as vendor facilities as necessary.

Physical Demands:

Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands

and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly

require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions

with other employees.

Qualifications:

• Bachelor of Science in electrical/electronic engineering or related engineering field.

• A minimum of six (6) + years of relevant work experience in performing the layout construction, and evaluation of a variety of Printed

Circuit Boards, fixtures and tools.

• Experience with product development a plus.

• Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes,

policies and tasks.

• Demonstrated personal computer skills, including spreadsheet, word processing, database management, and specialized applications.

• Advanced credential or professional certification in a relevant discipline/concentration desired.

• Six-Sigma knowledge and experience desired.

• Training and experience in manufacturing processes and methods desired, especially in the manufacturing of medical devices.

• 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.

• Ability to maintain regular and predictable attendance.

OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL DEPENDING ON EXPERIENCE.

NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.

Abbott Laboratories

Address

Westford, MA
USA

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