Quality Engineer

Regulatory Jobs; Buffalo (NY); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Paid time off

Life and disability insurance

Professional development opportunities

Job summary

Nissha Medical Technologies is seeking a Quality Engineer to join our Buffalo, NY Quality team. This role ensures manufacturing processes comply with product specifications, customer requirements, and regulatory standards, including ISO 9000 and 13485, while driving continuous improvement.

You will lead DFMEA/PFMEA activities, support product development, and collaborate with cross-functional teams to resolve issues, implement CAPA, and uphold QMS audits.

Qualifications

• 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

Responsibilities

• Ensure processes comply with the tolerances stated in product specifications and drawings, as well as QSR and ISO standards.
• Lead cross-functional teams to improve process and product understanding.
• Assist in determining and implementing the test and inspection activities required for quality inspection.
• Investigate and analyze manufacturing, customer, and supplier problems.
• Apply Lean Six Sigma methodologies to drive continuous improvement.

Skills

Quality engineering

Statistical methods

Manufacturing quality

Education

B.S. Degree in Mechanical Engineering

Job description

About Nissha Medical Technologies

Nissha Medical Technologies (NMT) is a global Contract Development and Manufacturing Organization (CDMO) where people, purpose, and technology come together to advance healthcare. Headquartered in the United States, NMT is the medical devices business unit and a wholly owned subsidiary of Nissha Co., Ltd., a publicly traded Japanese company based in Kyoto, Japan (TSE: 7915).

Across our global organization, our teams collaborate to design and manufacture innovative medical devices and solutions that make a real difference in patients’ lives. We partner closely with our customers to solve complex challenges, move ideas forward, and support products from concept through commercialization. Our work spans patient monitoring, surgical and interventional solutions, precision components, and emerging technologies, all grounded in a strong culture of quality, accountability, and continuous improvement.

At Nissha Medical Technologies, we believe our success is driven by our people. We foster an environment where curiosity is encouraged, teamwork is valued, and individuals are empowered to grow their skills and careers. If you’re motivated by meaningful work, collaboration, and the opportunity to help shape the future of healthcare, you’ll find a place to belong at NMT.

What You Will Do

Nissha Medical Technologies is looking for a Quality Engineer to join our Quality team in Buffalo, NY! ThisPosition is 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 compliances to corporate and regulatory requirements including ISO 9000 and 13485 standards.

• Ensure processes comply with the tolerances stated in product specifications and drawings, as well as QSR and ISO standards.
• Support product development activities, including DFMEA, PFMEA, PCP, PVP, TMV, and validation protocol reports (IQ, OQ, PQ).
• Lead cross-functional teams to improve process and product understanding.
• Serve as the primary interface for all customer quality requirements for specific devices and ensure those requirements are met.
• Assist in determining and implementing the test and inspection activities required for quality inspection.
• Investigate and analyze manufacturing, customer, and supplier problems.
• Resolve customer quality issues by executing Corrective and Preventive Action (CAPA) processes.
• Apply Lean Six Sigma methodologies and quality engineering tools to drive continuous improvement.
• Implement process improvements, including fixtures, tooling, production checks, and testing and inspection devices.
• Establish mechanisms to evaluate, measure, and monitor product quality to improve production process efficiency.
• Assist with troubleshooting manufacturing and engineering activities.
• Review and approve product designs.
• Participate in internal and external audits to ensure the effective implementation of the Quality Management System (QMS).

What You Bring

Core Qualifications

• 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

Preferred Qualifications

• Six Sigma Green Belt Certification preferred

• Knowledge of 21 CRF 820 and cGMP’s
• Ability to develop sound and simple systems to assure ISO and regulatory compliance

Professional Traits We Value

• 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

Compensation & Benefits

The expected salary range for this position is $70,000-$85,000. Actual compensation will be determined based on experience, skills, qualifications, and geographic location.

In addition, Nissha Medical Technologies offers a competitive total rewards package including medical, dental, and vision coverage, 401(k) with company match, paid time off, life and disability insurance, and professional development opportunities.

Equal Opportunity Statement

Nissha Medical Technologies is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected status under applicable law.