NPD Quality Engineer II

Position Overview

The Design Quality Engineer (DQE) II plans, coordinates, and manages the quality assurance (QA) activities associated with one or multiple New Product Development (NPD) and/or Sustaining Design Changes projects to ensure compliance to internal and external requirements during the development and commercialization of new products. The DQE II provides overall QA leadership, partners with the NPD organization, and manages the effective oversight of Design Quality activities, ensuring timely completion of deliverables that meet company standards.

• Represent Quality on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards.
• Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned project activities.
• Lead quality system development and implementation throughout the product life cycle.
• Provide oversight for internal and external metrology, incoming inspection, acceptance criteria, disposition of non‑conforming materials, and measurement system evaluations.
• Assure that all applicable elements and product technical standards that are applicable to a design category are effectively incorporated into new designs and into changes to designs.
• Review and approve/reject technical transfer plans and reports from the design transfer perspective; provide input to design and manufacturing documentation to ensure manufacturability and evaluability.
• Lead teams and ensure completion of Risk Management activities for new and/or modified products and processes, including risk assessment, authoring risk management plans and reports, and facilitating risk assessment activities with limited guidance required.
• Leads cross‑functional team on how to document changes using a risk‑based approach for determining requirements.
• Contribute to design input requirements from experience with previously reported problems from internal sources or external sources, competitive devices, and/or other related products.
• Develop and validate test methods.
• Establish effective corrective action plans; lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with moderate complexity.
• Review and approve product and process qualification and validation and other change control related documentation.
• Active role in improving and drafting internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
• Identify non‑conformance trends and develop technical investigation plans; investigate and analyze customer/internal complaints.
• Performs analytical measurements and experiments to qualify or resolve product and process issues.
• Track quality trends and initiate action items to resolve issues; manage assigned corrective actions.
• Support field quality and analyze field returns to determine root cause.
• Provide training and support for quality system processes and quality engineering practices.
• Provide support as a Quality Assurance Team member to work with Engineering and Systems Teams to resolve issues related to Design Verification and Design Validation.
• Clear understanding of Process Validation Principles and ability to support Process Qualification efforts (IQ, OQ, PQ etc.) for all classes of medical devices.

• Effective communication skills both verbal and written. Communicates effectively with internal teams and may present findings to small groups.
• Strong organizational skills as well as time management skills essential for project work.
• Self‑motivating and able to balance multiple priorities and tight deadlines with limited supervision.
• Strong writing, mathematics, and statistics skills.
• Demonstrated working knowledge of key medical device standards including 21 CFR 820…