Quality Operations Specialist
Nissha Medical Technologies

JOB DESCRIPTION

Role Summary

The Quality Operations Specialist supports day-to-day quality execution and essential site operations for a small, fast-moving product development site. This role ensures compliance continuity through consistent application of the Quality Management System (QMS) and provides hands-on support to development build activity, documentation readiness, and operational flow. This position partners closely with Buffalo Quality and Development Engineering to execute regulated processes locally and keep the site operating efficiently.

Key Responsibilities

Quality Execution & Compliance

• Execute core QMS activities at the Nashville site in alignment with Buffalo quality systems and procedures.
• Support quality processes including complaints, CAPA support, investigations/root cause activities, and documentation maintenance.
• Maintain audit readiness through consistent execution of quality requirements and timely completion of site-level quality records.
• Support internal and external audits by coordinating logistics, preparing documentation, and hosting auditors as needed.
• Ensure adherence to ISO 13485, FDA, and applicable GMP requirements, escalating compliance risks appropriately.

Development Build & Technical Support

• Provide hands-on support for development builds and regulated product activities, including following work instructions, drawings, and defined protocols.
• Partner with development engineering to support process execution, documentation updates, and controlled implementation of design or process changes.
• Assist with creation, improvement, and maintenance of controlled documentation, including work instructions, SOPs, process flows, and supporting records.

Site Operations & Execution

• Maintain oversight of site readiness through coordination of key operational activities such as calibration, preventive maintenance, and equipment availability.
• Coordinate site vendors and contractors to ensure timely completion of service work while maintaining compliance expectations.
• Support site logistical needs including controlled receiving activities, material movement support, and shipment coordination (as needed).
• Maintain compliance-related site requirements such as cleanroom/environmental monitoring documentation where applicable.
• Support training record execution and documentation completion to maintain compliance with internal and external requirements.

Systems & Cross-Functional Collaboration

• Serve as a site-level point of contact for quality-related system use and execution (ERP/PLM utilization and documentation discipline).
• Collaborate cross-functionally with Development Engineering, Quality, and Operations stakeholders to resolve issues and keep work moving forward.
• Identify opportunities to strengthen site processes, improve efficiency, and reduce compliance risk in a practical, scalable way.

Required Qualifications

• Bachelor's degree in a STEM-related discipline (Science, Engineering, or similar) preferred; Associate degree with strong regulated experience may be considered.
• Minimum 3 years of experience in a regulated environment (medical device strongly preferred).
• Working knowledge of ISO 13485, FDA/GMP expectations, and documentation-controlled environments.
• Experience supporting or executing QMS processes such as documentation control, investigations, calibration coordination, complaints, CAPA support, or audit support.
• Strong communication and collaboration skills with the ability to work across Quality and Engineering teams.
• Highly organized, adaptable, and comfortable operating in a small-site, evolving environment.

Preferred Qualifications

• ISO 13485 internal auditor certification or audit participation experience
• Lean / 5S / Continuous Improvement exposure
• Experience supporting development builds, process documentation, or design transfer activities

Nissha Medical Technologies is committed to fair, competitive, and market-informed pay for our employees. The pay range for this position is $80,000-100,000 Annual (USD). The successful candidate's particular combination of knowledge, skills, and experience will inform their specific compensation.

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 place!

What 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 together!
• Team 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!

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