New · posted Oct 27
Nissha Medical Technologies · Medical Devices
Quality Engineer
- Buffalo, NY
- On-site
- Full-time
- Senior & Principal
The role
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
What you need
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 Qualificationsnice to have
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
Skills named in this posting
What you'll do
Nissha Medical Technologies is looking for a Quality Engineer to join our Quality team in Buffalo, NY! This Position 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).
Pay and benefits
$70,000 – $85,000 a year
Employer providedThe 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.
Medical, dental, and vision coverage
401(k) with company match
Paid time off
Life and disability insurance
Professional development opportunities
Where you'll work
Buffalo, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Buffalo, NY
From the posting
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.
Equal opportunity, accessibility and legal noticesNissha Medical Technologies's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 28, 2026
Salary intelligence
How the pay compares
This role's midpoint is 36% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in New York17 roles publishing pay
Senior & Principal roles in the US323 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $70,000 | — | $85,000 |
| New York (middle half) | $81,500 | $104,000 | $118,500 |
| All US (middle half) | $104,000 | $122,000 | $142,250 |
This role: Nissha Medical Technologies's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 28, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 961 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Nissha Medical Technologies's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance6
- Lab testing and methods5
- Quality systems and risk5
- Documentation and SOPs2
- Investigations and CAPA2
- Collaboration and leadership2
- Validation and qualification1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Nissha Medical Technologies on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 3
- Locations
By discipline
- Quality4 100%
By level
- Associate & Specialist2 50%
- Manager1 25%
- Senior & Principal1 25%
More roles at Nissha Medical Technologies
- View role
Quality Supervisor
Buffalo, NYManagerMedical Devices$65K–$75K
- View role
Quality Technician I
New Richmond, WIAssociate & SpecialistMedical Devices$42K–$54K
- View role
Quality Inspector II
Colorado Springs, COAssociate & SpecialistMedical Devices$44K–$48K
Similar Quality Assurance roles elsewhere
- View role
Quality Engineer III
The Cretex CompaniesBrooklyn Park, MNSenior & PrincipalMedical Devices$91K–$136K
- View role
Senior Quality Engineer
MedtronicBoxborough, MASenior & PrincipalMedical Devices$98K–$148K
- View role
End-to-End (E2E) Distribution Excellence Quality & Compliance (Q&C) Lead
Johnson & JohnsonCoppell, TX +1 moreSenior & PrincipalMedical DevicesSalary not listed
- View role
Principal Quality Engineer
Johnson & JohnsonNew Brighton, MNSenior & PrincipalMedical Devices$102K–$177K
Quality Engineer at Nissha Medical Technologies
Open until filled. $70K–$85K a year, employer provided.