Lead Quality Engineer

Position: Lead Quality Engineer

Company: Reputable Medical Device Client

Location: Guildford, CT 06437

Duration: Full - Time

Environment: 5 days a week on site

Salary: $85,000 - $115,000

Required Skills & Experience

5+ years of experience as a Quality Engineer driving quality improvement and inspection for a manufacturing floor

5+ years of experience working in the Biomedical, Medical Device, or Automotive industry in an environment certified to ISO standards preferably tied to a quality management system such as ISO 13485, ISO or IATF 16949, or ISO 9001

Bachelor’s degree

Nice to Have Skills & Experience

Degree in Manufacturing or Mechanical field

ASQC Certified

Experience with CMM (Coordinate Measuring Machines)

Six Sigma Greenbelt Certification (or higher)

Experience using Minitab

Experience in GD&T

Job Description

Insight Global is seeking a full-time Lead Quality Engineer for a Bio-Medical Device company in Guilford, CT! You will be managing two Receiving Inspectors and report directly to the company president. The primary goal of this position is to ensure quality materials are being received from vendors prior to hitting the manufacturing floor and drive continuous improvement to quality systems so that quality medical device products are delivered to customers at the best cost.

Essential Duties and Responsibilities:

- Ensure manufacturing parts meet customer expectations, taking action when nonconformances are discovered.

- Collaborate with engineering to review manufacturing designs and make recommendations as necessary to support quality and cost effective production.

- Recommend and implement enhancements to the quality system to improve performance, increase customer satisfaction, and simplify processes to reduce costs.

- Analyze processes and recommend changes based on findings, following up to verify effectiveness.

- Determine necessary applications of Measurement Systems Analysis and Gauge R&R studies, conducting and documenting efforts.

- Participate in Failure Mode and Effects Analysis (FMEA), maintain Control Plans, and problem solve conducting root cause analysis with corrective action when necessary.

- Communicate with customer service, engineering, and manufacturing to resolve customer complaints and concerns related to quality.

- Lead the Material Review Board meeting, generating trend data and CAPA.

- Ensure the company’s readiness for all internal and external audits.

- Assist with quality reporting and management review processes.

Exact compensation may vary based on several factors, including skills, experience, and education.

Healthcare benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, financial protection benefits, as well as HSA, FSA, and DCFSA account options. 401k retirement account access is offered starting on the 90th day with employer matching after one year of service. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.