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iMPact Business Group
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http://www.impactbusinessgroup.com
http://www.impactbusinessgroup.com
USD
90000.00
100000.00
YEAR
true
Key Responsibilities:
Quality Engineer
Posted: 11/17/2023
2023-11-17
2024-01-04
Job Type:
Permanent/Direct Hire
Industry: Engineering
Job Number: 24600
Pay Rate: $ 90000.00 - $ 100000.00
Job Description
Quality Engineer
Our client, a Leader in the Medical Device Industry has an immediate opening for a Quality Engineer in New Haven, CT. This will be a permanent direct-hire position that will need to be onsite. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment.
Key Responsibilities:
- Lead day-to-day change management for products, processes, and procedures.
- Provide on-site support for sub-component and finished goods manufacturing at contract manufacturers and material suppliers, ensuring seamless implementation of new processes and equipment.
- Assist in the design and execution of process validations supporting manufacturing and scale-up efforts.
- Develop and enhance quality assurance tests, material testing procedures, and other quality processes.
- Collaborate closely with R&D to support the transfer of processes to commercial contract manufacturers.
- Contribute to the design control process, including the development of test protocols/reports, verification and validation, and risk management.
- Review technical/test protocols and reports for procedural compliance and statistical acceptability.
- Support engineering in the implementation and validation of manufacturing processes, testing procedures, and inspection requirements.
- Manage investigations and resolution of quality issues, fostering cross-functional partnerships for effective resolution.
- Stay current on best practices and statutory regulations governing the design, procurement, manufacture, marketing, and distribution of medical devices.
Requirements:
- Bachelor's degree in Engineering or related field
- 2 years of related experience in Quality Assurance or Quality Engineering.
- Understanding of 21CFR820, ISO13485, ISO14971.
- Knowledge of quality principles, systems, methods, problem-solving tools, and statistical principles.
- A driven self-starter and independently motivated individual who excels in a team environment.
Our client is an equal opportunity employer and advocate for workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, citizenship status, or veteran status
This position is not eligible for employer-based sponsorship.
Benefits
- Competitive compensation
- Excellent healthcare including medical, dental, vision and prescription coverage
- Short & long term disability plus life insurance -- cost paid fully by
- Retirement Savings Plan (401K) -- company matches your contributions dollar for dollar, with the potential for up to 7% per pay period
- Employee Stock Purchase Plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level course
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Ready to launch your career in the vibrant area around New Haven, Connecticut? Explore a plethora of exciting job opportunities in this bustling hub of innovation and culture. Boasting renowned landmarks like Yale University, the historic Shubert Theatre, and the stunning New Haven Green, this region offers a perfect blend of urban charm and natural beauty. With a thriving arts scene, delectable cuisines like the classic New Haven-style pizza, and an array of outdoor recreation options at East Rock Park and Long Wharf, this area is a haven for career growth and work-life balance. Join us in discovering the endless possibilities that await your professional journey in this enchanting corner of the Constitution State.
