Senior Quality Engineer

LanceSoft Inc; North Haven (CT); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading quality engineering firm located in North Haven, Connecticut, is seeking a Quality Engineer with extensive experience in design and manufacturing. The role involves performing quality engineering functions to support product development, leading teams of quality engineers, and ensuring compliance with standards. The ideal candidate will have a BS degree in Engineering, a minimum of 7 years' experience in the field, and strong skills in statistical methods and quality control. This is a crucial position in maintaining product quality and compliance in a regulated environment.

Qualifications

• Minimum 7 years' experience in design, manufacturing, or quality engineering position.
• Experience with analytical tools, statistics, and quality control methodologies.
• Experience in a regulated environment.

Responsibilities

• Perform Quality Engineering functions for product development.
• Oversee leadership for Quality Engineers and support project needs.
• Evaluate component and sub-assembly subcontractors for quality.

Skills

Quality Engineering

Design Verification

Reliability Engineering

Statistical Process Control

Failure Analysis

Education

BS degree in Engineering, Math or Physical Science

Tools

Minitab

DOE

Job description

Performs Quality Engineering functions in support of projects associated to product development/change including: design verification (design for six sigma), reliability engineering, component specification / approval, process evaluation and nonconforming product analysis in a project team environment.

Ensure that component and finished devices are properly specified and inspected, and the associated manufacturing processes are properly designed, analyzed and validated.

Evaluate component and sub-assembly subcontractors to ensure device quality and conformance to standards and regulations. Perform failure analysis to prevent or correct component and product failures as well as other risk management activities. Manage QA extended teams to ensure adequate support for all projects.

Oversee and provide leadership for Quality Engineers, Associate Quality Engineers and other personnel as necessary. Tracking timelines and facilitating the required Quality Engineering Tools.

Providing guidance to Divisional Quality Engineers and Associate Engineers with project and assuring proper and consistent implementation of the quality engineering tools.

Provide support to other quality groups to assure efficient completion of project requirements.

Experience

Minimum 7 years' experience in design, manufacturing, or quality engineering position (medical device experience preferred). Three years of experience can be substituted for an advanced degree in related discipline.

Experience with analytical tools and methods, including statistics (minitab preferred), DOE, and the use of computer software packages related to design, development and manufacturing. Statistical Quality control/statistical process control, design of experiments, failure mode and effects analysis. Experience in a regulated environment.

Qualifications

Education: BS degree in Engineering, Math Physical Science

Additional Information

All your information will be kept confidential according to EEO guidelines.