Quality Systems Specialist
About The Position
Nissha Medical Technologies – New Richmond is home to the Isometric Micro Molding Center of Excellence, where highly skilled teams take pride in solving some of the most challenging manufacturing problems in medical technology. Located in New Richmond, Wisconsin, this campus brings together deep expertise in micro molding, precision tooling, and micro automated assembly to support devices where precision, reliability, and miniaturization truly matter. Our New Richmond team plays a critical role in helping customers turn complex ideas into scalable, manufacturable solutions for applications such as drug delivery, surgical robotics, diagnostics, and minimally invasive devices. Collaboration is at the heart of how we work, engineers, toolmakers, operators, and quality professionals work side by side to push boundaries, improve processes, and continuously raise the bar. As part of Nissha Medical Technologies, the New Richmond site combines the agility and hands‑on culture of a specialized center of excellence with the resources and global reach of a worldwide CDMO. Nissha Medical Technologies is the medical devices business unit and a wholly owned subsidiary of Nissha Co., Ltd., a publicly held Japanese company headquartered in Kyoto, Japan (TSE: 7915). Together, our teams are united by a shared commitment to craftsmanship, innovation, and making a meaningful impact on healthcare.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs or related field (or equivalent experience)
- 2-4 years of experience in Quality Assurance, Quality Systems or Regulatory Affairs within the medical device industry.
- Strong knowledge of ISO 13485 and 21 CFR Part 11/820
Nice To Haves
- Certifications such as RAC, CQE or CQA area a plus
- Excellent analytical, organizational and communication skills
Responsibilities
- Lead and maintain integration of new global documentation; ensure documents comply with regulatory and company requirements
- Ensure all documents meet company formatting, version control and template standards prior to release or revision
- Maintain, distribute and archive controlled documents, including procedures, work instructions, forms and records
- Identify, investigate and resolve documentation inconsistencies, duplicates and obsolete records
- Provide support and guidance to employees across departments regarding document control processes and requirements
- Perform electronic and physical document filing and records management activities
- Participate in documentation system improvements and cross-functional quality projects
- Ensure training records are maintained and compliant with the system
- Lead onboard training for employees, ensuring timely completion and accurate training records
- Deliver training to peers and cross-functional team members as needed
- Participate in training systems improvements
- Support preparation for internal and external audits, including documentation readiness and follow-up actions
- Participating in internal and external audit activities as needed
- Lead and own the CAPA board process, including coordination, tracking and reporting of actions
Benefits
- medical, dental, and vision coverage
- 401(k) with company match
- paid time off
- life and disability insurance
- professional development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
