DEKA Research & Development · 1 day ago
NPI Quality Specialist
DEKA Research & Development is an innovative company focused on medical device manufacturing. The NPI Quality Specialist will support design transfer activities and quality operations, ensuring that tooling and manufacturing processes meet quality standards while coordinating with suppliers and engineering teams.
3D PrintingDeveloper PlatformManufacturingMedical Device
Responsibilities
Collaborate with suppliers to ensure that tooling and manufacturing processes meet quality standards and specifications for medical products
Develop and maintain relationships with suppliers to ensure timely delivery of validated tooling, equipment, and components
Work with suppliers to address non-conformances related to tooling or materials, and develop corrective actions in collaboration with engineering and validation teams
Coordinate tooling qualifications, ensuring tools meet all performance, safety, and regulatory standards before product manufacturing
Ensure process changes (e.g., tool changes, equipment upgrades) are assessed and validated appropriately to maintain product quality
Communicate effectively with validation personnel to align on protocols, testing, and timelines for process and tooling validation activities
Act as a liaison between suppliers, engineering, and quality teams to ensure alignment and resolution of issues related to tooling and process validation
Ensure proper documentation of tooling qualifications, process validations, and supplier-related activities according to standards
Coordinate the Review and approval of documentation related to tooling and process changes, ensuring traceability and compliance with design history files (DHF) and production records
Provide regular updates on the status of NPI tooling and process validation activities, including any challenges or risks
Track and report the status of validation milestones, tooling approvals, and supplier progress, ensuring adherence to project timelines
Qualification
Required
Bachelor's degree with 1 year of supplier management experience or 5 years of supplier management experience
Stable career progression and project coordination and/or project management experience through multiple project phases
Experience working in an engineering or technical environment
Experience with JIRA
Advanced proficiency in Microsoft Word & Excel
Strong computer skills with databases and software applications
Strong written and verbal communication skills
Demonstrated aptitude for learning technical information quickly and accurately
Ability to shift priorities efficiently in a fast-paced environment
Company
DEKA Research & Development
DEKA Research & Development provides technology solutions for power, mobility, and water applications along with fluid management.
H1B Sponsorship
DEKA Research & Development has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (13)
2023 (23)
2022 (16)
2021 (9)
2020 (7)
Funding
Current Stage
Late StageRecent News
2025-10-10
NH Business Review
2025-03-26
Company data provided by crunchbase