Shelton, United States
29 days ago
Lighthouse Professional Services, a division of Staffing 360 Solutions group of companies, has been providing contract and direct hire talent to client companies, ranging from small businesses to Fortune 500 corporations for over 50 years. Our offices are in New York, Connecticut, and Massachusetts, and we work with clients across the country. Our management and recruiting teams are led by experienced industry professionals. We invest in excellent working partnerships, powered by people.
We are currently seeking a Quality Engineer for a client in Shelton, CT.
Position Summary and Special Duties:
As a (an) Quality Engineer your day-to-day duties will consist of and may not be limited to:
Under direction of the Director of Quality, this position is responsible for providing Quality Engineering support on design control projects and serving as a Quality Engineering resource to suppliers. This position is also responsible for investigating complaints and non-conforming material reports and initiating corrective and preventive actions.
Main Job Duties/Responsibilities of the Quality Engineer:
- Participates in design control projects providing quality engineering support.
- Assists the design control project team with the development of essential design control deliverables.
- Develops inspection techniques, plan, and gauging techniques.
- Review’s engineering drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing (GD&T) and key characteristics for inspection plans and gauging.
- Participates in product transfers to assure design activities are complete and specific quality criteria are established.
- Serves as liaison to suppliers as the Quality Engineer.
- Uses quality tools to implement improvements including process flowcharting, pareto analysis, correlation and regression analysis, significance tests, statistical process control, gauge R&R, and trend analysis techniques.
- Performs supplier audits and participates in the qualification of new suppliers. Evaluates supplier quality data and initiates actions based on quality indicators.
- Assists with the development of protocols to ensure processes and products are validated with the appropriate level of confidence.
- Investigates and analyzes internal failures and customer complaints.
- Participates as a leader or key member of CAPA teams; identifies the need for CAPAs.
- Reviews non-conforming reports (NCR) and recommends/approves disposition of products; Initiates follow up actions to prevent recurrence.
- Reviews and approves Change Control Requests/Orders for quality function.
Quality Engineer Education and Experience:
- Bachelor’s Degree in Mechanical Engineering or related Engineering field.
- Minimum of 5 years of Quality Engineering experience in a medical device manufacturing environment. CQE, CRE, CQA - a plus.
- Must demonstrate knowledge of and proficiency with quality tools, such as GR&R and FMEA.
- Must demonstrate knowledge of recognized Quality System Standards and their application to the organizational QMS.
Quality Engineer Skills and Abilities:
- Strong attention to detail and accuracy.
- Excellent interpersonal skills – ability to work well with others.
- Excellent communication skills – both verbal and written.
- Excellent organization skills – plans work, executes plan and maintains organized work area.
- Proficient PC application skills to include Windows, Microsoft Word, Excel, Mini Tab and Solidworks (CAD) a plus.
- Duration: direct hire
- Location: Shelton, CT
- Salary: Negotiable