We are looking for a Quality Engineer at Nissha Medical Technologies for our facility in Wolcott, CT ! In this role, you will be responsible to assure that manufacturing processes comply with the product specification, customer requirements, and regulatory/government agencies requirements.  Control total quality and establish ways of evaluating the quality of products. Responsible to develop, modify, apply, and maintain, standards for quality operating methods, processes, systems, and procedures and ensure compliance of corporate and regulatory requirements including ISO 9000 and 13485 standards. 

Essential Job Functions include

1. Ensure processes complies with the tolerances stated on the product specification and drawings QSR and ISO standards.
2. Support product development activities i.e. DFMEA, PFMEA, PCP, PVP, TMV, and validation protocol reports IQ, OQ, PQ.
3. Lead cross functional teams to improve process and product understanding.
4. Act as main interface for all customer quality requirements for specific devices and responsible for meeting requirements.
5. Assist in determination and implementation of test and inspection activities required for quality inspection. 
6. Investigate and analyze manufacturing, customer, and supplier problems.
7. Resolve customer quality issues by executing Corrective Action Preventive Action (CAPA) processes.
8. Use Lean Six Sigma methodology and quality engineering tools to achieve continuous improvement.
9. Implements process improvements including fixtures, tooling, production checks, testing/inspection devices.
10. Establish mechanism to evaluate, measure, monitor and/or quality in our products to improve efficiency of the production process.
11. Assist in trouble shooting in manufacturing, and engineering activities. 
12. Review and approve product design.
13. Participate in internal/external audits to ensure the effective implementation of Quality Management System (QMS).

Requirements, Knowledge, Skills & Abilities 

• B.S. Degree in Mechanical Engineering or other Science related field
• Minimum 5 years’ experience in QE capacity engineering in a manufacturing environment; preferably in a medical or pharmaceutical environment
• CQE preferred
• Working experience with the application of statistical methods in quality assurance systems and processes
• Six Sigma Green Belt Certification preferred
• Strong written and oral communication skills
• Excellent organizational and interpersonal skills
• Ability to work effectively in a team environment
• Knowledge of 21 CRF 820 and cGMP’s
• Ability to develop sound and simple systems to assure ISO and regulatory compliance
• Provide recommendations based on business system results
• Well-developed verbal, numerical reasoning and analysis sills with ability to draw sound conclusions
• Ability to interact with operations management at all levels
• Ability to take initiative; completion of tasks in an accurate and timely manner; attention to detail

Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, gender expression,national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.
If you need assistance with completing the online application process, please call 716-849-6495.