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Quality Engineer

4 months ago

Buffalo, United States Nissha Medical Technologies Full time

Nissha Medical Technologies is excited to be looking for a Quality Engineer to add to our team This position will be responsible for assuring that manufacturing processes comply with the product specification, customer requirements, and regulatory/government agencies requirements. They will control total quality and establish ways of evaluating the quality of products. Also responsible to develop, modify, apply, and maintain, standards for quality operating methods, processes, systems, and procedures and ensure compliances to corporate and regulatory requirements including ISO 9000 and 13485 standards.Essential Job Functions1. 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).RequirementsB.S. Degree in Mechanical Engineering or other Science related fieldMinimum 5 years' experience in QE capacity engineering in a manufacturing environment; preferably in a medical or pharmaceutical environmentCQE preferredWorking experience with the application of statistical methods in quality assurance systems and processesSix Sigma Green Belt Certification preferredKnowledge, Skills, and AbilitiesStrong written and oral communication skillsExcellent organizational and interpersonal skillsAbility to work effectively in a team environmentKnowledge of 21 CRF 820 and cGMP'sAbility to develop sound and simple systems to assure ISO and regulatory complianceProvide recommendations based on business system resultsWell-developed verbal, numerical reasoning and analysis sills with ability to draw sound conclusionsAbility to interact with operations management at all levelsAbility to take initiative; completion of tasks in an accurate and timely manner; attention to detailStarting salary range of $70-80k, depending on experience + comprehensive benefit package offered.Why choose Nissha to build your career?At Nissha, you can be assured that you will be part of a dynamic, diverse team that is committed to bringing the best versions of ourselves each and every day. We recently received the "General Excellence" manufacturing award from Buffalo Business First, which highlights our dedication to quality, innovation, and sustainability. This recognition celebrates the hard work of our team in producing high-quality medical devices that meet industry standards and enhance patient care. If you are looking for meaningful work that motivates and inspires, you've come to the right placeWhat we offer that you'll love...Company Culture: At Nissha, we pride ourselves on cultivating an atmosphere of teamwork where all associates feel heard and valued. We may not all think the same, and we wouldn't have it any other way.Diversity & Inclusion: We are committed to equity, racial justice, and equal opportunity for all.Training and Development opportunities: Because we foster a culture of continuing education. Let's learn and grow togetherTeam Building, Connection, and Relationships: We support each other, celebrate our achievements and milestones together, and have FUN.Retirement: We know you want to retire comfortably and we're here to help Nissha offers a 401(k) Retirement Plan with an attractive employer contribution. Time Away from Work: Whether it is vacation or sick leave, we all need time to recharge. Paid time off is an essential associate benefit and a pillar of self-care.Engagement Activities: Recognition isn't just a once-a-year occurrence at Nissha. We celebrate our team members year-round with summer picnics, holiday parties, and employee spotlight events, just to name a few.Commitment to Wellness: We offer various opportunities to learn about your health, be healthier, and get rewarded for your healthy lifestyle by offering reduced medical premiums.And so much MORE