How you will make an impact as a NPI Quality Specialist:
- 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.
- 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 as fast paced environment
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
Top Skills
What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester.
DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality.
DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
