NPI Quality Specialist

DEKA Research & Development•Manchester, NH

38d

About The Position

The NPI Quality Specialist supports design transfer activities and quality operations in an innovative, fast-paced, medical device-manufacturing environment. This role focuses on coordinating the development, review and maintenance of control plans, risk management files, validation protocols, process capability studies; and other QMS documentation to support initial qualification and commercial launch of medical products. The role will have direct interaction with suppliers, engineers, and manufacturing personal.

Requirements

Bachelor’s degree with 1 year of supplier management experience or 5 years of supplier management experience
Project coordination and/or project management experience
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

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.