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 III in New Haven, CT. The Quality Engineer III provides cross-functional quality support for the development, maintenance, and improvement of manufacturing activities and new product development activities for the Technology team in New Haven, CT. This individual will lead day-to-day change management, support implementation/validation of new equipment and processes, navigate quality integration of processes and procedures, and work closely with R&D to support new product and process development.
Key Duties and Responsibilities
- Support day-to-day change management for products, processes, and procedures.
- On-site support of sub-component and finished goods level manufacturing activities at contract manufacturers and material suppliers including troubleshooting and implementation of process, equipment, validations, and improvements.
- Assist in the design and execution of process validations that supports existing manufacturing and scale-up efforts.
- Develop and improve quality assurance tests and other material or process testing procedures.
- Support manufacturing in the transfer of processes from R&D to commercial contract manufacturers.
- Support engineering in 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.
- Assist engineering in the implementation and validation of manufacturing processes, testing procedures and inspection requirements.
- Support and manage investigations and resolution of quality issues (i.e. customer complaints, products nonconformances, corrective/preventive actions).
- Direct the resolution of quality issues by fostering cross-functional partnerships through effective communication, engagement activities, and influencing behaviors.
- Keep current on all applicable best practices and statutory regulations governing the design, procurement, manufacture, marketing, and distribution of medical devices.
- Bachelor’s degree in engineering or related technical discipline, master’s degree preferred.
- 2 years of related experience in Quality Assurance or Quality Engineering
- Thorough understanding of 21CFR820/ISO13485/ISO14971
- Knowledge of quality principles, systems, methods, problem-solving tools, and statistical principles
- 0-30% Travel
- Competitive compensation
- Excellent healthcare including medical, dental, vision and prescription coverage.
- Short- & long-term disability plus life insurance -- cost paid fully.
- Retirement Savings Plan (401K) -- 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 courses
Duration: Contract to Permanent
Location: Danvers, MA.
Salary: $ Depending on Skills, Experience, and Education.
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume and salary expectations and any references.