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Sr Quality Engineer - Exempt

LanceSoft Inc

North Haven, CT

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
American Society for Quality (ASQ), Analysis Skills, Certified Quality Engineer (CQE), Change Control, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Design Failure Mode and Effects Analysis (DFMEA), Design Verification, Detail Oriented, Documentation, Electromechanical Design, Establish Priorities, Hazard Analysis, Healthcare, ISO (International Organization for Standardization), Manufacturing, Manufacturing/Industrial Processes, Mathematics, Medical Equipment, Minitab, Multitasking, Physical Science, Process Validation, Product Development, Product Support, Project Development, Project Lifecycle, Quality Engineering, Regulations, Reporting Skills, Requirements Management, Requirements Validation/Verification, Risk Analysis, Risk Management, Statistics, Surgical Supplies, Test Requirements, Validation Plan, Validation Testing
LOCATION
North Haven, CT
POSTED
30+ days ago
Join our dynamic team in North Haven, CT, where you can contribute to shaping the future of healthcare. As a Senior Quality Engineer, you will support new product development for Surgical Instruments. This role involves working closely with a cross-functional core team to drive product quality and continuous improvement. Top Technical Skills Required Risk Management (Hazard Analysis, DFMEA, UFMEA) Design Verification Authoring and Execution General NPD QE skillset (Change control, CAPA, ISO 13485 understanding) Position Responsibilities Actively participate in the product development cycle by reviewing project documentation, participating in product risk assessments, and developing verification and validation testing requirements. Assess overall product risk by facilitating the development of risk management tools such as risk management plans, hazard identification, and complaint analysis. Collect, analyze, and interpret statistical data, providing reports to management as required. Contribute to Design and Process Validation initiatives by planning and reviewing validation and qualification activities. Provide solutions to a wide range of challenges, working independently to develop imaginative and practicable solutions. Basic Qualifications B.S. degree in Engineering, Math, Physical Science, or equivalent field with 5 years of work experience in engineering or Quality. Preferred: M.S. degree in Engineering, Math, Physical Science, or equivalent field with 4 years of work experience in engineering or Quality. Specialized Skills or Experience Fundamental understanding of electro-mechanical designs and manufacturing processes. Experience in a regulated industry. Experience with Minitab or similar statistical analysis tools. Good interpersonal skills and ability to work effectively in a team environment. Strong attention to detail and ability to prioritize multiple projects. Nice to Have ASQ Certified Quality Engineering (CQE) Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971, and 60601 requirements. Understanding of software and hardware interface. Join us in North Haven, CT, and be part of a team that is pushing the limits of technology to change healthcare worldwide. Together, we can make a difference.

About the Company

L

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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